A Phase 2 interventional study of FE 201836 and Desmopressin in Nocturia, sponsored by Ferring Pharmaceuticals. Completed at 72 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Ferring Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults
Exclusion Criteria:
Hyponatraemia:
Use of any prohibited therapy listed below:
FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
Drug: FE 201836 · Drug: Placebo ODT
FE 201836 350 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836 · Drug: Placebo ODT
FE 201836 250 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836 · Drug: Placebo ODT
FE 201836 150 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836 · Drug: Placebo ODT
FE 201836 100 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836 · Drug: Placebo ODT
FE 201836 50 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836 · Drug: Placebo ODT
Placebo oral solution and placebo ODT, administered once daily
Drug: Placebo oral solution · Drug: Placebo ODT
Desmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects)
Drug: Desmopressin · Drug: Placebo oral solution
Desmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects)
Drug: Desmopressin · Drug: Placebo oral solution
Oral solution for daily intake
Also known as: Velmupressin
Desmopressin Orally Disintegrating Tablet (ODT)
Also known as: NOCDURNA
Manufactured to mimic experimental drug
Manufactured to mimic experimental drug
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
Time frame: Baseline, during 12 weeks of treatment
Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2. MMRM=Mixed Model for Repeated Measurements. For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).
Time frame: Baseline, Week 1
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Time frame: Baseline, Week 4
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Time frame: Baseline, Week 8
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Time frame: Baseline, Week 12
Responder Rate in Nocturnal Voids at Week 1
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Time frame: Week 1
Responder Rate in Nocturnal Voids at Week 4
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Time frame: Week 4
Responder Rate in Nocturnal Voids at Week 8
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Time frame: Week 8
Responder Rate in Nocturnal Voids at Week 12
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Time frame: Week 12
Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
Defined as 50% reduction in nocturnal voids from baseline. Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Time frame: During 12 weeks of treatment
Change From Baseline in Mean NI Diary Total Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 1
Change From Baseline in Mean NI Diary Total Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 4
Change From Baseline in Mean NI Diary Total Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 8
Change From Baseline in Mean NI Diary Total Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Time frame: Baseline, during 12 weeks of treatment
Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint. Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
Time frame: During 12 weeks of treatment
Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint. Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
Time frame: During 12 weeks of treatment
Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 1
Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 4
Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 8
Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Time frame: Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Time frame: Baseline, during 12 weeks of treatment
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Time frame: Week 1
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Time frame: Week 4
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Time frame: Week 8
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Time frame: Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 1
Change From Baseline in PGI-S Scores at Week 4
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 4
Change From Baseline in PGI-S Scores at Week 8
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 8
Change From Baseline in PGI-S Scores at Week 12
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 12
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 1
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 4
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 8
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Time frame: Baseline, Week 12
Change From Baseline in ISI at Week 4
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia). Change from baseline in visit-specific ISI is presented in this endpoint. Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Time frame: Baseline, Week 4
Change From Baseline in ISI at Week 8
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia). Change from baseline in visit-specific ISI is presented in this endpoint. Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Time frame: Baseline, Week 8
Change From Baseline in ISI at Week 12
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia). Change from baseline in visit-specific ISI is presented in this endpoint. Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Time frame: Baseline, Week 12
Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Time frame: Baseline, Week 1
Change From Baseline in Mean Duration of FUSP at Week 4
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Time frame: Baseline, Week 4
Change From Baseline in Mean Duration of FUSP at Week 8
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Time frame: Baseline, Week 8
Change From Baseline in Mean Duration of FUSP at Week 12
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Time frame: Baseline, Week 12
Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Time frame: Baseline, During 12 Weeks of Treatment
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed. Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented. Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Time frame: Baseline, Week 1
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed. Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented. Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Time frame: Baseline, Week 12
Change From Baseline in Mean NUV in Week 1
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning. The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Time frame: Baseline, Week 1
Change From Baseline in Mean NUV at Week 12
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning. The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Time frame: Baseline, Week 12
A total of 71 sites were authorized to recruit subjects for the trial between July 2017 and July 2019. The trial sites that screened subjects to the trial were: 5 in Belgium, 10 in Canada, 5 in Czech Republic, 2 in Germany, 5 in Hungary, 1 in Poland and 43 in the Unites States of America (USA).
| Milestone | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25 µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|---|---|
| Started | 60 | 27 | 24 | 14 | 13 | 34 | 87 | 26 | 17 |
| Completed | 52 | 24 | 22 | 14 | 12 | 33 | 81 | 25 | 15 |
| Not completed | 8 | 3 | 2 | 0 | 1 | 1 | 6 | 1 | 2 |
| Withdrew: Adverse event | 3 | 1 | 0 | 0 | 1 | 1 | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol deviation | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Other | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
| nocturnal voids | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment | -1.06 (-1.28 to -0.86) | -0.99 (-1.20 to -0.78) | -0.89 (-1.12 to -0.69) | -0.80 (-1.00 to -0.62) | -0.77 (-0.97 to -0.59) | -0.76 (-0.95 to -0.58) | -0.76 (-0.95 to -0.58) |
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2. MMRM=Mixed Model for Repeated Measurements. For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).
| nocturnal voids | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Number of Nocturnal Voids at Week 1 | -0.714 (-1.005 to -0.424) | -1.162 (-1.577 to -0.747) | -0.722 (-1.149 to -0.296) | -0.520 (-1.058 to 0.017) | -0.722 (-1.318 to -0.126) | -0.325 (-0.709 to 0.059) | -0.575 (-0.842 to -0.308) |
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
| nocturnal voids | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Number of Nocturnal Voids at Week 4 | -1.078 (-1.345 to -0.811) | -1.330 (-1.708 to -0.952) | -0.784 (-1.181 to -0.386) | -0.471 (-0.969 to 0.028) | -0.952 (-1.469 to -0.435) | -0.518 (-0.866 to -0.171) | -0.912 (-1.152 to -0.673) |
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
| nocturnal voids | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Number of Nocturnal Voids at Week 8 | -1.085 (-1.394 to -0.776) | -1.177 (-1.603 to -0.751) | -0.965 (-1.414 to -0.516) | -0.490 (-1.037 to 0.058) | -1.077 (-1.671 to -0.484) | -0.786 (-1.187 to -0.386) | -0.953 (-1.233 to -0.672) |
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
| nocturnal voids | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Number of Nocturnal Voids at Week 12 | -1.256 (-1.568 to -0.944) | -1.120 (-1.558 to -0.683) | -0.850 (-1.301 to -0.400) | -0.674 (-1.206 to -0.142) | -1.053 (-1.650 to -0.456) | -0.921 (-1.317 to -0.524) | -0.957 (-1.237 to -0.677) |
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
| odd of response | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Responder Rate in Nocturnal Voids at Week 1 | 0.844 (0.457 to 1.558) | 1.202 (0.510 to 2.833) | 0.682 (0.280 to 1.662) | 0.818 (0.269 to 2.490) | 0.810 (0.240 to 2.738) | 0.513 (0.227 to 1.157) | 0.480 (0.272 to 0.848) |
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
| odd of response | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Responder Rate in Nocturnal Voids at Week 4 | 1.199 (0.633 to 2.270) | 5.851 (1.511 to 22.650) | 0.634 (0.255 to 1.575) | 0.534 (0.165 to 1.731) | 1.760 (0.470 to 6.596) | 0.683 (0.301 to 1.550) | 1.235 (0.686 to 2.224) |
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
| odd of response | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Responder Rate in Nocturnal Voids at Week 8 | 1.395 (0.717 to 2.715) | 3.398 (1.150 to 10.043) | 1.928 (0.721 to 5.155) | 0.877 (0.286 to 2.688) | 1.039 (0.302 to 3.569) | 1.489 (0.638 to 3.474) | 1.503 (0.806 to 2.803) |
Defined as 50% reduction in nocturnal voids from baseline. Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
| odd of response | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Responder Rate in Nocturnal Voids at Week 12 | 3.914 (1.830 to 8.370) | 1.891 (0.693 to 5.163) | 1.824 (0.694 to 4.795) | 0.854 (0.279 to 2.611) | 1.400 (0.401 to 4.893) | 1.395 (0.611 to 3.181) | 1.590 (0.844 to 2.993) |
Defined as 50% reduction in nocturnal voids from baseline. Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint. The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
| odd of response | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Responder Rate in Nocturnal Voids During 12 Weeks of Treatment | 1.129 (0.808 to 1.753) | 1.095 (0.772 to 1.661) | 1.032 (0.711 to 1.543) | 0.934 (0.597 to 1.378) | 0.887 (0.555 to 1.253) | 0.849 (0.534 to 1.187) | 0.834 (0.514 to 1.180) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Total Score at Week 1 | -7.55 (-11.67 to -3.43) | -21.91 (-28.15 to -15.68) | -10.90 (-17.17 to -4.63) | -8.93 (-17.15 to -0.72) | -9.68 (-18.41 to -0.94) | -8.75 (-14.27 to -3.23) | -8.07 (-11.48 to -4.65) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Total Score at Week 4 | -12.62 (-16.89 to -8.35) | -17.44 (-23.80 to -11.08) | -14.37 (-20.96 to -7.78) | -11.23 (-19.82 to -2.65) | -22.23 (-31.11 to -13.35) | -13.29 (-19.00 to -7.58) | -14.20 (-17.77 to -10.64) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Total Score at Week 8 | -16.03 (-20.49 to -11.57) | -23.22 (-29.79 to -16.64) | -15.10 (-21.85 to -8.35) | -12.04 (-20.77 to -3.32) | -19.23 (-28.62 to -9.83) | -14.11 (-20.00 to -8.22) | -14.83 (-18.50 to -11.16) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Total Score at Week 12 | -16.92 (-21.66 to -12.18) | -24.44 (-31.52 to -17.35) | -14.68 (-21.94 to -7.42) | -10.13 (-19.37 to -0.88) | -22.59 (-32.46 to -12.71) | -17.18 (-23.39 to -10.96) | -17.45 (-21.36 to -13.53) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment | -12.40 (-14.71 to -8.59) | -12.69 (-15.07 to -10.53) | -12.75 (-15.16 to -10.57) | -12.77 (-15.21 to -10.59) | -12.77 (-15.23 to -10.54) | -12.78 (-15.18 to -10.50) | -12.77 (-15.18 to -10.47) |
The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint. Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
| percentage of nights | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment | 67.2 (58.2 to 76.2) | 77.5 (64.9 to 90.2) | 64.5 (51.0 to 78.0) | 55.3 (38.3 to 72.3) | 73.2 (55.1 to 91.2) | 61.4 (49.3 to 73.5) | 62.0 (53.8 to 70.2) |
The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint. Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
| percentage of nights | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment | 23.3 (16.3 to 30.3) | 28.8 (19.0 to 38.6) | 17.3 (6.8 to 27.8) | 12.9 (-0.3 to 26.1) | 14.8 (0.8 to 28.8) | 21.5 (12.1 to 30.9) | 23.0 (16.6 to 29.4) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Overall Impact Score at Week 1 | -10.98 (-16.40 to -5.56) | -30.39 (-38.62 to -22.17) | -15.51 (-23.85 to -7.17) | -11.77 (-22.69 to -0.85) | -2.79 (-14.29 to 8.70) | -12.26 (-19.57 to -4.95) | -13.46 (-17.89 to -9.03) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Overall Impact Score at Week 4 | -22.17 (-28.25 to -16.09) | -26.07 (-35.09 to -17.05) | -19.35 (-28.80 to -9.90) | -18.36 (-30.66 to -6.07) | -17.95 (-30.50 to -5.41) | -21.40 (-29.54 to -13.26) | -21.75 (-26.74 to -16.77) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Overall Impact Score at Week 8 | -28.13 (-34.76 to -21.50) | -34.97 (-44.69 to -25.25) | -21.71 (-31.80 to -11.62) | -19.03 (-32.06 to -6.00) | -23.84 (-37.71 to -9.96) | -20.70 (-29.45 to -11.94) | -25.32 (-30.69 to -19.95) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NI Diary Overall Impact Score at Week 12 | -30.47 (-37.49 to -23.45) | -36.76 (-47.18 to -26.34) | -20.84 (-31.65 to -10.02) | -15.32 (-29.10 to -1.54) | -28.89 (-43.40 to -14.39) | -27.13 (-36.35 to -17.91) | -30.03 (-35.74 to -24.33) |
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment | -6.50 (-10.57 to -2.85) | -6.25 (-9.78 to -3.03) | -6.11 (-9.49 to -2.90) | -6.00 (-9.28 to -2.70) | -5.98 (-9.29 to -2.58) | -5.97 (-9.32 to -2.57) | -5.96 (-9.42 to -2.49) |
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1 | 2.475 (2.261 to 2.689) | 2.045 (1.723 to 2.367) | 2.708 (2.385 to 3.031) | 2.786 (2.363 to 3.209) | 2.781 (2.316 to 3.245) | 2.758 (2.482 to 3.033) | 2.745 (2.571 to 2.919) |
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4 | 2.121 (1.866 to 2.376) | 2.191 (1.813 to 2.569) | 2.447 (2.039 to 2.855) | 2.521 (1.995 to 3.047) | 2.385 (1.859 to 2.910) | 2.582 (2.244 to 2.921) | 2.596 (2.386 to 2.806) |
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8 | 1.843 (1.572 to 2.113) | 1.887 (1.493 to 2.281) | 2.528 (2.109 to 2.947) | 2.286 (1.761 to 2.811) | 2.155 (1.587 to 2.723) | 2.273 (1.917 to 2.629) | 2.573 (2.355 to 2.791) |
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse). Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12 | 1.667 (1.357 to 1.977) | 1.671 (1.224 to 2.119) | 2.656 (2.167 to 3.146) | 2.452 (1.855 to 3.049) | 1.678 (1.052 to 2.304) | 2.384 (1.994 to 2.774) | 2.490 (2.240 to 2.740) |
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1 | -0.739 (-0.927 to -0.552) | -0.970 (-1.253 to -0.688) | -0.811 (-1.094 to -0.529) | -0.643 (-1.012 to -0.273) | -0.417 (-0.840 to 0.007) | -0.719 (-0.984 to -0.454) | -0.593 (-0.746 to -0.440) |
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in PGI-S Scores at Week 4 | -0.837 (-1.015 to -0.659) | -1.025 (-1.292 to -0.758) | -0.798 (-1.081 to -0.516) | -0.749 (-1.115 to -0.383) | -0.656 (-1.033 to -0.278) | -0.936 (-1.189 to -0.684) | -0.898 (-1.045 to -0.750) |
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in PGI-S Scores at Week 8 | -1.132 (-1.322 to -0.942) | -1.410 (-1.688 to -1.132) | -0.825 (-1.114 to -0.536) | -0.643 (-1.004 to -0.281) | -0.816 (-1.215 to -0.418) | -1.013 (-1.279 to -0.747) | -0.800 (-0.953 to -0.647) |
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe). Change from baseline in visit-specific PGI-S is presented in this endpoint. Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in PGI-S Scores at Week 12 | -1.181 (-1.383 to -0.979) | -1.338 (-1.630 to -1.045) | -0.894 (-1.208 to -0.579) | -0.638 (-1.020 to -0.257) | -1.168 (-1.571 to -0.764) | -1.041 (-1.312 to -0.770) | -0.853 (-1.016 to -0.690) |
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1 | -0.649 (-0.922 to -0.376) | -1.072 (-1.441 to -0.703) | -0.748 (-1.125 to -0.370) | -0.458 (-0.942 to 0.026) | -0.346 (-0.955 to 0.262) | -0.376 (-0.714 to -0.039) | -0.570 (-0.799 to -0.341) |
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4 | -0.896 (-1.161 to -0.630) | -0.940 (-1.294 to -0.586) | -0.712 (-1.083 to -0.340) | -0.606 (-1.079 to -0.132) | -1.096 (-1.698 to -0.493) | -0.861 (-1.193 to -0.530) | -0.665 (-0.885 to -0.445) |
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8 | -0.972 (-1.273 to -0.672) | -1.044 (-1.423 to -0.664) | -0.991 (-1.389 to -0.594) | -0.499 (-1.001 to 0.004) | -1.012 (-1.691 to -0.333) | -0.881 (-1.240 to -0.522) | -0.731 (-0.968 to -0.495) |
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely). Change from baseline in visit-specific Hsu Bother is presented in this endpoint. Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12 | -0.992 (-1.306 to -0.679) | -1.249 (-1.663 to -0.834) | -0.700 (-1.132 to -0.267) | -0.880 (-1.416 to -0.343) | -0.974 (-1.676 to -0.272) | -0.921 (-1.303 to -0.540) | -0.769 (-1.027 to -0.511) |
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia). Change from baseline in visit-specific ISI is presented in this endpoint. Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in ISI at Week 4 | -6.589 (-8.046 to -5.133) | -6.652 (-8.689 to -4.616) | -5.630 (-7.772 to -3.487) | -5.428 (-8.200 to -2.656) | -4.510 (-7.996 to -1.023) | -6.372 (-8.291 to -4.452) | -5.277 (-6.493 to -4.061) |
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia). Change from baseline in visit-specific ISI is presented in this endpoint. Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in ISI at Week 8 | -7.643 (-9.140 to -6.147) | -8.091 (-10.116 to -6.067) | -6.693 (-8.799 to -4.588) | -6.959 (-9.668 to -4.250) | -5.707 (-9.283 to -2.131) | -7.167 (-9.055 to -5.280) | -6.408 (-7.603 to -5.213) |
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia). Change from baseline in visit-specific ISI is presented in this endpoint. Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
| score on a scale | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in ISI at Week 12 | -7.807 (-9.427 to -6.188) | -9.329 (-11.619 to -7.040) | -6.355 (-8.733 to -3.977) | -6.193 (-9.195 to -3.191) | -5.002 (-8.865 to -1.138) | -7.908 (-10.016 to -5.800) | -6.678 (-8.018 to -5.338) |
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
| minutes | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1 | 122.9 (86.2 to 159.7) | 187.0 (132.3 to 241.7) | 106.0 (49.6 to 162.4) | 91.7 (18.7 to 164.8) | 82.9 (2.5 to 163.4) | 51.3 (3.9 to 98.7) | 81.1 (50.8 to 111.4) |
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
| minutes | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Duration of FUSP at Week 4 | 164.5 (127.9 to 201.0) | 211.0 (156.3 to 265.7) | 132.3 (75.2 to 189.4) | 89.5 (15.1 to 163.9) | 122.0 (46.8 to 197.3) | 95.5 (48.6 to 142.5) | 150.2 (120.4 to 180.0) |
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
| minutes | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Duration of FUSP at Week 8 | 160.4 (112.4 to 208.3) | 225.4 (157.9 to 293.0) | 190.2 (118.9 to 261.6) | 136.8 (48.3 to 225.4) | 163.2 (68.7 to 257.8) | 164.3 (104.9 to 223.7) | 161.0 (122.6 to 199.5) |
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
| minutes | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean Duration of FUSP at Week 12 | 178.5 (132.5 to 224.5) | 160.0 (93.3 to 226.6) | 180.7 (112.2 to 249.2) | 111.5 (29.7 to 193.2) | 141.1 (51.3 to 230.9) | 166.2 (110.5 to 221.8) | 162.8 (126.9 to 198.7) |
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint. The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
| minutes | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment | 154.98 (130.41 to 189.10) | 150.23 (130.20 to 181.15) | 145.95 (128.21 to 170.90) | 140.74 (120.51 to 160.16) | 139.19 (117.86 to 157.42) | 138.13 (115.62 to 157.24) | 137.45 (114.12 to 157.30) |
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed. Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented. Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
| mL/min | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1 | -0.575 (-0.687 to -0.463) | -0.635 (-0.801 to -0.468) | -0.610 (-0.779 to -0.440) | -0.459 (-0.678 to -0.239) | -0.523 (-0.766 to -0.280) | -0.328 (-0.474 to -0.182) | -0.402 (-0.494 to -0.310) |
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed. Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented. Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
| mL/min | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12 | -0.648 (-0.789 to -0.508) | -0.606 (-0.805 to -0.408) | -0.735 (-0.937 to -0.533) | -0.458 (-0.693 to -0.223) | -0.685 (-0.945 to -0.425) | -0.651 (-0.812 to -0.490) | -0.515 (-0.619 to -0.412) |
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning. The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
| mL | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NUV in Week 1 | -328.8 (-395.3 to -262.3) | -371.8 (-470.4 to -273.3) | -352.4 (-452.8 to -252.1) | -265.5 (-395.5 to -135.6) | -312.6 (-455.9 to -169.3) | -218.2 (-304.9 to -131.6) | -241.6 (-296.3 to -186.9) |
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning. The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
| mL | FE 201836 500 ug (Randomized Treatment Period) | FE 201836 350 ug (Randomized Treatment Period) | FE 201836 250 ug (Randomized Treatment Period) | FE 201836 150 ug (Randomized Treatment Period) | FE 201836 100 ug (Randomized Treatment Period) | FE 201836 50 ug (Randomized Treatment Period) | Placebo (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|
| Change From Baseline in Mean NUV at Week 12 | -367.3 (-447.1 to -287.5) | -392.4 (-505.2 to -279.5) | -411.3 (-526.0 to -296.7) | -284.2 (-418.4 to -149.9) | -393.5 (-541.9 to -245.1) | -403.2 (-495.5 to -310.9) | -317.8 (-377.1 to -258.5) |
Collected over Enrichment period: Treatment-emergent adverse events (AEs) occurring in the time interval from V2 (active run-in) to V4 (randomization), including AEs with missing start date. Randomized treatment period: Treatment-emergent AEs occurring in the time interval from V4 to end-of-trial.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FE 201836 500 µg (Enrichment Period) | 0/531 (0%) | 2/531 (0.4%) | 0/531 (0%) |
| FE 201836 500 µg (Randomized Treatment Period) | 0/60 (0%) | 1/60 (1.7%) | 16/60 (26.7%) |
| FE 201836 350 µg (Randomized Treatment Period) | 0/27 (0%) | 2/27 (7.4%) | 3/27 (11.1%) |
| FE 201836 250 µg (Randomized Treatment Period) | 0/24 (0%) | 1/24 (4.2%) | 3/24 (12.5%) |
| FE 201836 150 µg (Randomized Treatment Period) | 0/14 (0%) | 0/14 (0%) | 8/14 (57.1%) |
| FE 201836 100 µg (Randomized Treatment Period) | 0/13 (0%) | 1/13 (7.7%) | 5/13 (38.5%) |
| FE 201836 50 µg (Randomized Treatment Period) | 0/34 (0%) | 0/34 (0%) | 7/34 (20.6%) |
| Placebo (Randomized Treatment Period) | 0/87 (0%) | 2/87 (2.3%) | 16/87 (18.4%) |
| Desmopressin 25 µg (Randomized Treatment Period) | 0/26 (0%) | 0/26 (0%) | 8/26 (30.8%) |
| Desmopressin 50 µg (Randomized Treatment Period) | 0/17 (0%) | 0/17 (0%) | 9/17 (52.9%) |
| Event | FE 201836 500 µg (Enrichment Period) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25 µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|---|---|---|
| Abdominal pain upperGastrointestinal disorders | 0/531 | 0/60 | 0/27 | 0/24 | 0/14 | 1/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| SyncopeNervous system disorders | 0/531 | 0/60 | 0/27 | 1/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Facial bones fractureInjury, poisoning and procedural complications | 0/531 | 0/60 | 0/27 | 1/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Subdural haematomaInjury, poisoning and procedural complications | 0/531 | 0/60 | 0/27 | 1/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Staphylococcal infectionInfections and infestations | 0/531 | 0/60 | 1/27 | 0/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Urinary tract infectionInfections and infestations | 0/531 | 0/60 | 1/27 | 0/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/531 | 0/60 | 1/27 | 0/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/531 | 0/60 | 1/27 | 0/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Serum sickness-like reactionImmune system disorders | 0/531 | 1/60 | 0/27 | 0/24 | 0/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| ColitisGastrointestinal disorders | 0/531 | 0/60 | 0/27 | 0/24 | 0/14 | 0/13 | 0/34 | 1/87 | 0/26 | 0/17 |
| Event | FE 201836 500 µg (Enrichment Period) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25 µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) |
|---|---|---|---|---|---|---|---|---|---|---|
| Accidental overdoseInjury, poisoning and procedural complications | 0/531 | 0/60 | 0/27 | 1/24 | 0/14 | 0/13 | 1/34 | 3/87 | 0/26 | 4/17 |
| Gamma-glutamyltransferase increasedInvestigations | 0/531 | 2/60 | 0/27 | 0/24 | 2/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Alanine aminotransferase increasedInvestigations | 0/531 | 0/60 | 0/27 | 0/24 | 2/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| Aspartate aminotransferase increasedInvestigations | 0/531 | 0/60 | 0/27 | 0/24 | 2/14 | 0/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| VomitingGastrointestinal disorders | 0/531 | 0/60 | 0/27 | 0/24 | 2/14 | 0/13 | 1/34 | 1/87 | 0/26 | 1/17 |
| Hepatic enzyme increasedInvestigations | 0/531 | 0/60 | 0/27 | 0/24 | 0/14 | 0/13 | 0/34 | 0/87 | 3/26 | 0/17 |
| NauseaGastrointestinal disorders | 0/531 | 3/60 | 1/27 | 2/24 | 0/14 | 0/13 | 1/34 | 3/87 | 0/26 | 1/17 |
| AnaemiaBlood and lymphatic system disorders | 0/531 | 1/60 | 0/27 | 0/24 | 0/14 | 1/13 | 1/34 | 1/87 | 0/26 | 0/17 |
| Hand fractureInjury, poisoning and procedural complications | 0/531 | 0/60 | 0/27 | 0/24 | 0/14 | 1/13 | 0/34 | 0/87 | 0/26 | 0/17 |
| HyponatraemiaMetabolism and nutrition disorders | 0/531 | 3/60 | 2/27 | 0/24 | 0/14 | 1/13 | 0/34 | 0/87 | 0/26 | 1/17 |
| Age, Continuous(years) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 59.0 ± 14.1 | 58.0 ± 14.3 | 60.8 ± 13.0 | 63.9 ± 7.5 | 61.5 ± 9.2 | 59.1 ± 10.4 | 58.9 ± 13.9 | 51.1 ± 11.1 | 60.9 ± 9.5 | 58.8 ± 12.8 |
| Age, Customized(years) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| <65 years old | 35 | 19 | 14 | 6 | 6 | 21 | 52 | 24 | 11 | 188 |
| >=65 years old | 25 | 8 | 10 | 8 | 7 | 13 | 35 | 2 | 6 | 114 |
| Sex: Female, Male(Participants) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 40 | 18 | 16 | 5 | 8 | 16 | 51 | 26 | 0 | 180 |
| Male | 20 | 9 | 8 | 9 | 5 | 18 | 36 | 0 | 17 | 122 |
| Ethnicity (NIH/OMB)(Participants) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 17 | 9 | 6 | 3 | 7 | 12 | 35 | 12 | 4 | 105 |
| Not Hispanic or Latino | 42 | 18 | 18 | 11 | 6 | 22 | 51 | 14 | 13 | 195 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 3 |
| Asian | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 3 | 2 | 0 | 1 | 1 | 5 | 6 | 4 | 28 |
| White | 52 | 24 | 22 | 14 | 11 | 31 | 78 | 19 | 13 | 264 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline body mass index (BMI)(kg/m^2) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 30.66 ± 6.05 | 29.91 ± 4.64 | 29.56 ± 6.50 | 32.03 ± 8.26 | 31.52 ± 4.60 | 30.93 ± 6.16 | 29.54 ± 5.14 | 31.89 ± 7.99 | 31.05 ± 6.49 | 30.44 ± 6.00 |
| Mean Number of Nocturnal Voids(nocturnal voids) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 2.88 ± 0.84 | 3.01 ± 0.72 | 3.10 ± 1.11 | 2.98 ± 0.84 | 3.33 ± 0.82 | 3.24 ± 1.18 | 3.09 ± 0.83 | 3.38 ± 1.45 | 3.16 ± 1.22 | 3.09 ± 0.98 |
| Mean Nocturnal Urine Volume (NUV)(mL) | FE 201836 500 µg (Randomized Treatment Period) | FE 201836 350 µg (Randomized Treatment Period) | FE 201836 250 µg (Randomized Treatment Period) | FE 201836 150 µg (Randomized Treatment Period) | FE 201836 100 µg (Randomized Treatment Period) | FE 201836 50 µg (Randomized Treatment Period) | Placebo (Randomized Treatment Period) | Desmopressin 25µg (Randomized Treatment Period) | Desmopressin 50 µg (Randomized Treatment Period) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 804.6 ± 313.8 | 766.0 ± 242.1 | 897.3 ± 373.6 | 803.1 ± 304.7 | 892.4 ± 206.7 | 879.9 ± 354.1 | 752.3 ± 269.5 | 839.3 ± 286.4 | 803.5 ± 425.8 | 808.8 ± 307.5 |
4 further baseline measures are reported on the registry.
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Ferring Pharmaceuticals