A Phase 2 interventional study of Orvepitant Maleate and Placebo in Chronic Refractory Cough, sponsored by Nerre Therapeutics Ltd.. Completed at 66 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by Nerre Therapeutics Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total).
All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 315 is above the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →Nerre Therapeutics Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Orvepitant 10mg tablet, once daily for 12 weeks
Drug: Orvepitant Maleate
Orvepitant 20mg tablet, once daily for 12 weeks
Drug: Orvepitant Maleate
Orvepitant 30mg tablet, once daily for 12 weeks
Drug: Orvepitant Maleate
Placebo to match tablet, once daily for 12 weeks
Drug: Placebo
Tablet, once daily, oral
Tablet, once daily, oral
Change From Baseline to Week 12 in Awake Objective Cough Frequency
Objective cough frequency measured by ambulatory cough monitoring device
Time frame: Baseline to Week 12
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline
Objective cough frequency measured by ambulatory cough monitoring device
Time frame: Baseline to Week 2
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline
Objective cough frequency measured by ambulatory cough monitoring device
Time frame: Week 4
Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 2
Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 4
Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 8
Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 12
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 2
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 4
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 8
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 12
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 2
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 4
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 8
Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 12
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 2
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 4
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 8
Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 12
Global Rating of Change in Cough Frequency at Week 2
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 2
Global Rating of Change in Cough Frequency at Week 4
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 4
Global Rating of Change in Cough Frequency at Week 8
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 8
Global Rating of Change in Cough Frequency at Week 12
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 12
Global Rating of Change in Cough Severity at Week 2
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 2
Global Rating of Change in Cough Severity at Week 4
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 4
Global Rating of Change in Cough Severity at Week 8
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 8
Global Rating of Change in Cough Severity at Week 12
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Week 12
The first subject was enrolled (screened and consented) on 22-May-2017; the first subject was randomised on 31-Jan-2017. The last subject was enrolled on 28-Sep-2018. The last subject last visit (study completion) was 24-Jan-2019. Subjects were recruited from a mixture of specialised standalone clinics and clinics within hospitals.
| Milestone | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Started | 79 | 78 | 79 | 79 |
| Completed | 69 | 74 | 69 | 75 |
| Not completed | 10 | 4 | 10 | 4 |
| Withdrew: Lack of efficacy | 1 | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Unable to attend follow-up due to illness | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 3 | 1 | 7 | 0 |
| Withdrew: Withdrawal by subject | 4 | 2 | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 |
Objective cough frequency measured by ambulatory cough monitoring device
| coughs per hour (log transformed) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change From Baseline to Week 12 in Awake Objective Cough Frequency | -0.185 ± 0.3258 | -0.192 ± 0.3405 | -0.271 ± 0.4055 | -0.243 ± 0.3225 |
Objective cough frequency measured by ambulatory cough monitoring device
| coughs per hour (log transformed) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline | -0.180 ± 0.2791 | -0.181 ± 0.3142 | -0.215 ± 0.2515 | -0.139 ± 0.2892 |
Objective cough frequency measured by ambulatory cough monitoring device
| coughs per hour (log transformed) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline | -0.188 ± 0.3292 | -0.231 ± 0.3665 | -0.211 ± 0.2994 | -0.169 ± 0.2699 |
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Total score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline | 2.41 ± 3.309 | 2.37 ± 3.252 | 2.93 ± 3.010 | 1.24 ± 2.714 |
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Total score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline | 2.50 ± 3.416 | 2.15 ± 3.490 | 2.98 ± 3.163 | 1.61 ± 3.132 |
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Total score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline | 2.78 ± 3.535 | 2.19 ± 3.602 | 2.82 ± 3.960 | 1.34 ± 3.222 |
The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Total score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline | 2.38 ± 3.609 | 2.09 ± 3.736 | 3.23 ± 4.007 | 1.50 ± 3.586 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time | -17.7 ± 26.06 | -10.5 ± 27.78 | -13.5 ± 22.93 | -6.3 ± 19.24 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time | -17.9 ± 27.11 | -9.4 ± 26.76 | -15.9 ± 25.02 | -7.8 ± 22.36 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time | -21.0 ± 30.37 | -9.9 ± 29.57 | -18.6 ± 27.24 | -8.2 ± 23.58 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time | -18.8 ± 31.27 | -11.6 ± 27.33 | -20.1 ± 29.33 | -10.6 ± 24.46 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time | -12.8 ± 28.96 | -7.8 ± 26.76 | -6.2 ± 24.97 | -3.9 ± 27.62 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time | -10.1 ± 32.87 | -7.9 ± 27.52 | -5.8 ± 27.96 | -2.7 ± 27.99 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time | -11.5 ± 32.65 | -6.8 ± 29.07 | -9.8 ± 28.73 | -2.2 ± 28.95 |
The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time | -8.9 ± 35.99 | -7.1 ± 26.88 | -9.6 ± 30.24 | -1.5 ± 33.74 |
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline | -20.8 ± 24.59 | -12.0 ± 25.09 | -13.8 ± 22.03 | -7.0 ± 20.35 |
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline | -19.0 ± 26.93 | -12.0 ± 26.67 | -17.3 ± 24.73 | -8.8 ± 24.26 |
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline | -23.8 ± 28.00 | -14.5 ± 27.55 | -19.7 ± 26.80 | -11.0 ± 24.78 |
The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
| Score | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline | -23.7 ± 27.30 | -12.6 ± 28.57 | -22.9 ± 28.43 | -11.8 ± 26.50 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 4 | 10 | 5 | 11 |
| About the same | 35 | 37 | 34 | 44 |
| Better | 34 | 30 | 37 | 19 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 9 | 8 | 6 | 12 |
| About the same | 32 | 36 | 37 | 39 |
| Better | 28 | 32 | 31 | 25 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 11 | 17 | 10 | 20 |
| About the same | 22 | 31 | 37 | 38 |
| Better | 34 | 27 | 25 | 17 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 7 | 13 | 7 | 13 |
| About the same | 32 | 33 | 31 | 37 |
| Better | 28 | 28 | 29 | 24 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 7 | 8 | 4 | 12 |
| About the same | 33 | 39 | 35 | 44 |
| Better | 33 | 30 | 37 | 18 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 9 | 7 | 7 | 14 |
| About the same | 32 | 43 | 31 | 37 |
| Better | 28 | 26 | 36 | 25 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 8 | 12 | 6 | 15 |
| About the same | 26 | 36 | 35 | 42 |
| Better | 33 | 27 | 31 | 18 |
In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
| Participants | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| Worse | 5 | 15 | 8 | 16 |
| About the same | 38 | 33 | 30 | 36 |
| Better | 24 | 26 | 29 | 22 |
Collected over Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Orvepitant 10mg | 0/79 (0%) | 1/79 (1.3%) | 63/79 (79.7%) |
| Orvepitant 20mg | 0/78 (0%) | 1/78 (1.3%) | 48/78 (61.5%) |
| Orvepitant 30mg | 0/79 (0%) | 3/79 (3.8%) | 53/79 (67.1%) |
| Placebo | 0/79 (0%) | 1/79 (1.3%) | 40/79 (50.6%) |
| Event | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| DehydrationMetabolism and nutrition disorders | 0/79 | 1/78 | 0/79 | 0/79 |
| Intestinal anastomosis complicationInjury, poisoning and procedural complications | 0/79 | 0/78 | 1/79 | 0/79 |
| HypertensionVascular disorders | 1/79 | 0/78 | 0/79 | 0/79 |
| BradycardiaCardiac disorders | 1/79 | 0/78 | 0/79 | 0/79 |
| Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/79 | 0/78 | 0/79 | 1/79 |
| Suicide attemptPsychiatric disorders | 0/79 | 0/78 | 1/79 | 0/79 |
| AnxietyPsychiatric disorders | 0/79 | 0/78 | 1/79 | 0/79 |
| Event | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo |
|---|---|---|---|---|
| FatigueGeneral disorders | 13/79 | 13/78 | 11/79 | 4/79 |
| HeadacheNervous system disorders | 7/79 | 10/78 | 7/79 | 4/79 |
| Viral upper respiratory tract infectionInfections and infestations | 8/79 | 7/78 | 4/79 | 10/79 |
| Upper respiratory tract infectionInfections and infestations | 5/79 | 4/78 | 3/79 | 9/79 |
| Back painMusculoskeletal and connective tissue disorders | 4/79 | 1/78 | 6/79 | 0/79 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 5/79 | 1/78 | 4/79 | 3/79 |
| DizzinessNervous system disorders | 5/79 | 4/78 | 5/79 | 1/79 |
| SomnolenceNervous system disorders | 2/79 | 4/78 | 5/79 | 0/79 |
| ParaesthesiaNervous system disorders | 4/79 | 0/78 | 0/79 | 1/79 |
| NauseaGastrointestinal disorders | 2/79 | 1/78 | 4/79 | 3/79 |
| Age, Categorical(Participants) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 44 | 56 | 37 | 183 |
| >=65 years | 33 | 34 | 23 | 42 | 132 |
| Age, Continuous(years) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 62.29 ± 9.850 | 59.86 ± 13.173 | 59.47 ± 10.020 | 62.24 ± 11.815 | 60.97 ± 11.313 |
| Sex: Female, Male(Participants) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 65 | 69 | 60 | 59 | 253 |
| Male | 14 | 9 | 19 | 20 | 62 |
| Ethnicity (NIH/OMB)(Participants) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | 4 | 6 |
| Not Hispanic or Latino | 74 | 74 | 77 | 74 | 299 |
| Unknown or Not Reported | 5 | 3 | 1 | 1 | 10 |
| Region of Enrollment(participants) | Orvepitant 10mg | Orvepitant 20mg | Orvepitant 30mg | Placebo | Total |
|---|---|---|---|---|---|
| North America | 51 | 49 | 51 | 51 | 202 |
| Europe | 28 | 29 | 28 | 28 | 113 |
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Nerre Therapeutics Ltd.