A Phase 4 interventional study of Lyrica (pregabalin) and Placebo in Postherpetic Neuralgia ( PHN ), sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 22 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 223 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lyrica (pregabalin)
Drug: Placebo
Capsule, 300 mg/d, BID, 8 weeks treatment
Capsule, 300 mg/d, BID, 8 weeks treatment
Baseline Mean Pain Score
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time frame: Baseline
Change From Baseline in Mean Pain Score at Endpoint
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Time frame: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8
The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.
Time frame: Baseline and weekly from Weeks 1 to 8
Baseline Mean Sleep Interference Score
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
Time frame: Baseline
Change From Baseline in Mean Sleep Interference Score at Endpoint
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
Time frame: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.
Time frame: Baseline and weekly from Weeks 1 to 8
Percentage of 30 Percent (%) Responders at Endpoint
The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.
Time frame: End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8
SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
Time frame: Baseline; Weeks 1, 3, 5, and 8
Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Time frame: Baseline
Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
Time frame: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
Time frame: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.
Time frame: Baseline
Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Percentage of Participants Who Had Optimal Sleep at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
Time frame: Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Clinical Global Impression of Change (CGIC) Score at Endpoint
The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Time frame: Day 57 (Week 8)/Early Termination (Study Endpoint)
Patient Global Impression of Change (PGIC) Score at Endpoint
The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
Time frame: Day 57 (Week 8)/Early Termination (Study Endpoint)
Baseline Hospital Anxiety and Depression Scale (HADS) Scores
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time frame: Baseline
Change From Baseline in HADS Anxiety Total Score at Endpoint
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
Change From Baseline in HADS Depression Total Score at Endpoint
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
Time frame: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
223 participants were randomized, as stated on clinicaltrials.gov. However, 1 was randomized by mistake, was considered a screen failure, and was not given any medication. As such, the actual number of participants randomized and assigned to treatment was 222.
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 112 | 110 |
| Treated | 111 | 109 |
| Completed | 98 | 92 |
| Not completed | 14 | 18 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Adverse event | 6 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 5 |
| Withdrew: Did not meet entrance criteria | 0 | 2 |
| Withdrew: Insufficient clinical response | 0 | 2 |
| Withdrew: Did not receive treatment | 1 | 1 |
| Withdrew: Other | 2 | 4 |
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline Mean Pain Score | 5.93 ± 1.304 | 6.08 ± 1.266 |
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in Mean Pain Score at Endpoint | -1.81 ± 0.137 | -1.09 ± 0.142 |
The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Week 1 change from baseline | -0.62 ± 0.108 | -0.12 ± 0.111 |
| Week 2 change from baseline | -1.00 ± 0.109 | -0.35 ± 0.112 |
| Week 3 change from baseline | -1.23 ± 0.109 | -0.65 ± 0.112 |
| Week 4 change from baseline | -1.36 ± 0.110 | -0.85 ± 0.114 |
| Week 5 change from baseline | -1.50 ± 0.110 | -0.99 ± 0.114 |
| Week 6 change from baseline | -1.70 ± 0.110 | -1.11 ± 0.114 |
| Week 7 change from baseline | -1.78 ± 0.111 | -1.07 ± 0.114 |
| Week 8 change from baseline | -1.91 ± 0.111 | -1.21 ± 0.114 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline Mean Sleep Interference Score | 3.81 ± 2.436 | 4.54 ± 2.027 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in Mean Sleep Interference Score at Endpoint | -1.24 ± 0.145 | -0.70 ± 0.150 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Week 1 change from baseline | -0.52 ± 0.124 | 0.01 ± 0.128 |
| Week 2 change from baseline | -0.82 ± 0.124 | -0.16 ± 0.128 |
| Week 3 change from baseline | -0.92 ± 0.125 | -0.35 ± 0.129 |
| Week 4 change from baseline | -0.96 ± 0.125 | -0.51 ± 0.130 |
| Week 5 change from baseline | -1.02 ± 0.126 | -0.62 ± 0.130 |
| Week 6 change from baseline | -1.13 ± 0.126 | -0.74 ± 0.130 |
| Week 7 change from baseline | -1.27 ± 0.126 | -0.79 ± 0.130 |
| Week 8 change from baseline | -1.31 ± 0.126 | -0.84 ± 0.131 |
The DPRS consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.
| percentage of participants | Pregabalin | Placebo |
|---|---|---|
| Percentage of 30 Percent (%) Responders at Endpoint | 52.3 (42.6 to 61.8) | 30.6 (22.1 to 40.2) |
SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Sensory score, Baseline | 8.24 ± 5.276 | 8.00 ± 4.939 |
| Sensory score, Week 1 change (N=111, 106) | -1.68 ± 3.776 | -0.29 ± 3.009 |
| Sensory score, Week 3 change (N=107, 101) | -2.97 ± 3.852 | -1.05 ± 3.810 |
| Sensory score, Week 5 change (N=102, 96) | -3.31 ± 4.496 | -1.79 ± 4.058 |
| Sensory score, Week 8 change (N=98, 93) | -3.61 ± 4.299 | -1.94 ± 4.418 |
| Affective score, Baseline | 1.25 ± 2.038 | 1.31 ± 2.124 |
| Affective score, Week 1 change (N=111, 105) | -0.61 ± 1.602 | -0.28 ± 1.404 |
| Affective score, Week 3 change (N=107, 100) | -0.80 ± 1.772 | -0.46 ± 1.507 |
| Affective score, Week 5 change (N=102, 95) | -0.85 ± 2.036 | -0.59 ± 1.512 |
| Affective score, Week 8 change (N=97,90) | -0.96 ± 1.941 | -0.66 ± 1.630 |
| Total score, Baseline | 9.50 ± 6.621 | 9.29 ± 6.465 |
| Total score, Week 1 change (N=111, 106) | -2.29 ± 4.486 | -0.57 ± 3.494 |
| Total score, Week 3 change (N=107, 101) | -3.77 ± 4.761 | -1.51 ± 4.654 |
| Total score, Week 5 change (N=102, 96) | -4.17 ± 5.632 | -2.37 ± 5.035 |
| Total score, Week 8 change (N=98, 93) | -4.57 ± 5.117 | -2.53 ± 5.308 |
The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| VAS | 60.39 ± 13.064 | 62.60 ± 12.252 |
| PPI | 2.33 ± 0.940 | 2.42 ± 0.738 |
The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in Pain VAS From the SF-MPQ at Endpoint | -20.71 ± 1.412 | -12.53 ± 1.451 |
The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in PPI Scale From the SF-MPQ at Endpoint | -0.79 ± 0.078 | -0.42 ± 0.080 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Sleep disturbance score | 36.09 ± 25.542 | 35.08 ± 22.365 |
| Snoring score | 29.19 ± 32.450 | 30.83 ± 35.017 |
| Awaken short of breath score | 9.91 ± 21.213 | 8.07 ± 18.282 |
| Quantity of sleep score | 6.05 ± 1.534 | 5.97 ± 1.524 |
| Sleep adequacy score | 57.66 ± 31.449 | 60.46 ± 29.008 |
| Somnolence score | 32.25 ± 19.950 | 30.89 ± 17.816 |
| Sleep problems index score | 31.38 ± 20.691 | 29.27 ± 17.292 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint | -11.97 ± 1.821 | -4.76 ± 1.871 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint | -2.00 ± 2.043 | -3.73 ± 2.131 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint | -0.10 ± 1.895 | 0.26 ± 1.988 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint | 0.69 ± 0.108 | 0.25 ± 0.111 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.
| percentage of participants | Pregabalin | Placebo |
|---|---|---|
| Percentage of Participants Who Had Optimal Sleep at Endpoint | 49.5 (39.4 to 59.6) | 40.6 (30.7 to 51.1) |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint | 10.44 ± 2.325 | 8.64 ± 2.403 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint | 0.33 ± 1.613 | -0.54 ± 1.668 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint | -7.38 ± 1.427 | -4.54 ± 1.471 |
The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Clinical Global Impression of Change (CGIC) Score at Endpoint | 2.55 ± 0.086 | 3.18 ± 0.090 |
The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Patient Global Impression of Change (PGIC) Score at Endpoint | 2.68 ± 0.083 | 3.17 ± 0.086 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Anxiety total score | 3.22 ± 3.921 | 3.37 ± 3.466 |
| Depression total score | 3.45 ± 3.963 | 3.47 ± 3.387 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in HADS Anxiety Total Score at Endpoint | -0.92 ± 0.233 | -0.71 ± 0.241 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.
| units on a scale | Pregabalin | Placebo |
|---|---|---|
| Change From Baseline in HADS Depression Total Score at Endpoint | -0.65 ± 0.209 | -0.55 ± 0.217 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 2/111 (1.8%) | 40/111 (36%) |
| Placebo | — | 0/109 (0%) | 21/109 (19.3%) |
| Event | Pregabalin | Placebo |
|---|---|---|
| Respiratory tract infectionInfections and infestations | 1/111 | 0/109 |
| Cerebral ischaemiaNervous system disorders | 1/111 | 0/109 |
| Event | Pregabalin | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 27/111 | 4/109 |
| NasopharyngitisInfections and infestations | 5/111 | 9/109 |
| Oedema peripheralGeneral disorders | 7/111 | 2/109 |
| Dry mouthGastrointestinal disorders | 6/111 | 3/109 |
| SomnolenceNervous system disorders | 6/111 | 5/109 |
All randomized and treated participants were included in the baseline characteristics summarization.
| Age, Customized(participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| 18-44 years | 4 | 3 | 7 |
| 45-64 years | 39 | 47 | 86 |
| More than or equal to (>=)65 years | 68 | 59 | 127 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 54 | 47 | 101 |
| Male | 57 | 62 | 119 |
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.