Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01271933
Collaborator
(none)
441
52
2
16
8.5
0.5
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
441 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)
Actual Study Start Date
:
Mar 1, 2011
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pregabalin
|
Drug: pregabalin
controlled release tablet; 165-495 mg/day; given once daily
|
| Placebo Comparator: Placebo
|
Drug: placebo
matching placebo tablet; given once daily
|
Outcome Measures
Primary Outcome Measures
- Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) [Randomization to Week 19]
The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).
- Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event [Randomization to Week 19]
Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.
Secondary Outcome Measures
- Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 [Baseline, Weeks 1, 2, 3, 4, 5, 6]
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
- Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 [Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).
- Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit [Baseline, Double blind endpoint visit (Week 19)]
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).
- Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 [Baseline, Weeks 1, 2, 3, 4, 5, 6]
The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).
- Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 [Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]
The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).
- Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit [Baseline, Double blind endpoint visit (Week 19)]
The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).
- Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 [Baseline, Weeks 1, 2, 3, 4, 5, 6]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 [Baseline, Weeks 1, 2, 3, 4, 5, 6]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 [Baseline, Weeks 1, 2, 3, 4, 5, 6]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 [Baseline, Weeks 1, 2, 3, 4, 5, 6]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 [Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 [Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 [Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 [Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit [Baseline, Double blind endpoint visit (Week 19)]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit [Baseline, Double blind endpoint visit (Week 19)]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit [Baseline, Double blind endpoint visit (Week 19)]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night.
- Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit [Baseline, Double blind endpoint visit (Week 19)]
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent).
- Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period) [Baseline, Week 6]
Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).
- Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period) [Baseline, Week 19]
Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).
- Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II [Baseline, Week 6]
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.
- Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep [Baseline, Week 6]
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.
- Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II [Baseline, Week 19]
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.
- Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep [Baseline, Week 19]
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.
- Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 [Week 6]
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
- Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 [Week 19]
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
- Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 [Baseline, Week 6]
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.
- Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 [Baseline, Week 19]
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.
- Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6 [Baseline, Week 6]
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
- Double-Blind Phase: Change From Baseline in HADS Score at Week 19 [Baseline, Week 19]
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
- Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 [Baseline, Week 6]
The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.
- Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 [Baseline, Week 19]
The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.
- Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 [Baseline, Week 6]
The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.
- Double-Blind Phase: Change From Baseline in MFI Score at Week 19 [Baseline, Week 19]
The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.
- Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 [Week 6]
The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.
- Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 [Week 19]
The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.
- Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 [Baseline, Week 6]
WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.
- Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 [Baseline, Week 19]
WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19) [Baseline, Double blind end point visit (Week 19)]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.
Other Outcome Measures
- Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 [Baseline, Weeks 3, 4, 5, 6 and 7]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.
- Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 [Baseline, Weeks 3, 4, 5, 6 and 7]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).
- Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 [Baseline, Weeks 3, 4, 5, 6 and 7]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.
- Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 [Baseline, Weeks 3, 4, 5, 6 and 7]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.
- Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 [Baseline, Weeks 3, 4, 5, 6 and 7]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 [Baseline, Weeks 11, 12, 13, 14 and 15]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 [Baseline, Weeks 11, 12, 13, 14 and 15]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 [Baseline, Weeks 11, 12, 13, 14 and 15]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 [Baseline, Weeks 11, 12, 13, 14 and 15]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 [Baseline, Weeks 11, 12, 13, 14 and 15]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19) [Baseline, Double blind end point visit (Week 19)]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19) [Baseline, Double blind end point visit (Week 19)]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements).
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19) [Baseline, Double blind end point visit (Week 19)]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.
- Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19) [Baseline, Double blind end point visit (Week 19)]
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.
- Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) [Week 1 to Week 7 and Week 11 to Week 20]
C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients must have fibromyalgia.
Exclusion Criteria:
- Patients with other painful conditions cannot participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andrew O. Schreiber, MD | Orange | California | United States | 92868 |
| 2 | Apex Research Institute | Santa Ana | California | United States | 92705 |
| 3 | Paddock Park Clinical Research | Ocala | Florida | United States | 34474 |
| 4 | Broward Research Group | Pembroke Pines | Florida | United States | 33026 |
| 5 | Meridien Research | Tampa | Florida | United States | 33606 |
| 6 | Arthritis Care Center | Moline | Illinois | United States | 61265 |
| 7 | Davis Clinic, Inc | Indianapolis | Indiana | United States | 46250 |
| 8 | Central Kentucky Research Associates, Inc. | Lexington | Kentucky | United States | 40509 |
| 9 | Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | United States | 42431 |
| 10 | Boston Clinical Trials | Boston | Massachusetts | United States | 02131 |
| 11 | Beacon Clinical Research, LLC | Brockton | Massachusetts | United States | 02301 |
| 12 | The Center for Pharmaceutical Research, PC | Kansas City | Missouri | United States | 64114 |
| 13 | Mercy Health Research | Saint Louis | Missouri | United States | 63141 |
| 14 | Quality Clinical Research, Inc. | Omaha | Nebraska | United States | 68114 |
| 15 | AB Clinical Trials | Las Vegas | Nevada | United States | 89119 |
| 16 | Albuquerque Neuroscience, Incorporated | Albuquerque | New Mexico | United States | 87109 |
| 17 | Social Psychiatry Research Institute | Brooklyn | New York | United States | 11235 |
| 18 | Trinity Health Organization | Minot | North Dakota | United States | 58701 |
| 19 | University of Cincinnati Medical Center | Cincinnati | Ohio | United States | 45219 |
| 20 | Radiant Research, | Columbus | Ohio | United States | 43212 |
| 21 | Midwest Clinical Research Center | Dayton | Ohio | United States | 45417 |
| 22 | Sunstone Medical Research, LLC | Medford | Oregon | United States | 97504 |
| 23 | Allegheny Pain Management | Altoona | Pennsylvania | United States | 16602 |
| 24 | East Penn RheumatologyAssociates, P.C. | Bethlehem | Pennsylvania | United States | 18015 |
| 25 | Clinical Research Associates, Inc. | Nashville | Tennessee | United States | 37203 |
| 26 | FutureSearch Trials of Neurology | Austin | Texas | United States | 78731 |
| 27 | R/D Clinical Research, Inc. | Lake Jackson | Texas | United States | 77566 |
| 28 | Fatigue Consultation Clinic | Salt Lake City | Utah | United States | 84102 |
| 29 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22911 |
| 30 | Tacoma Center for Arthritis Research, PS | Tacoma | Washington | United States | 98405-2308 |
| 31 | Dr. Alexander McIntyre Inc. | Penticton | British Columbia | Canada | V2A 4M4 |
| 32 | Rivergrove Medical Clinic | Winnipeg | Manitoba | Canada | R2V 4W3 |
| 33 | Maritime Research Center | Bathurst | New Brunswick | Canada | E2A 4X7 |
| 34 | Clinique Medicale Nepisiguit | Bathurst | New Brunswick | Canada | E2A 4Z9 |
| 35 | Tri-Hospital Sleep Laboratory West | Mississauga | Ontario | Canada | L5B 4M4 |
| 36 | Canadian Phase Onward Inc. | Toronto | Ontario | Canada | M3H 5S4 |
| 37 | Sleep & Alertness Research Inc. | Toronto | Ontario | Canada | M6J 3S3 |
| 38 | West Island Rheumatology Research Associates | Pointe Claire | Quebec | Canada | H9R 3J1 |
| 39 | Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1H 1Z1 |
| 40 | Groupe de Recherche en Rhumatologie et Maladie Osseuses (GRMO Inc.) | Quebec | Canada | G1V 3M7 | |
| 41 | Mahavir Hospital & Research Centre | Hyderabad | Andhra Pradesh | India | 500 004 |
| 42 | Chanre Rheumatology & Immunology Center & Research | Bangalore | Karnataka | India | 560 079 |
| 43 | Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | India | 411 004 |
| 44 | Sahyadri Clinical Research & Development Center, | Pune | Maharashtra | India | 411 004 |
| 45 | Sahyadri Speciality Hospital | Pune | Maharashtra | India | 411004 |
| 46 | Punjab Rheumatology Centre | Ludhiana | Punjab | India | 141 001 |
| 47 | Department of Rheumatology | Lucknow | Uttar Pradesh | India | 226 018 |
| 48 | Indian Spinal Injuries Centre | New Delhi | India | 110 070 | |
| 49 | Chang Gung Medical Foundation-Linkou Branch | Kwei Shan Town | Taoyuan County | Taiwan | 333 |
| 50 | Chang-Hua Christian Hospital | Changhua | Taiwan | 500 | |
| 51 | China Medical University Hospital | Taichung | Taiwan | 404 | |
| 52 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01271933
Other Study ID Numbers:
- A0081245
- FIBROMYALGIA
First Posted:
Jan 7, 2011
Last Update Posted:
Jan 22, 2021
Last Verified:
Aug 1, 2018
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was performed in 4 countries at 50 centers. |
|---|---|
| Pre-assignment Detail | Baseline phase was from Visit 1 to Visit 2. Eligible participants entered single blind (SB) phase (Visit 2 to Visit 6) [6 weeks]. Responders with at least 50% improvement in pain from baseline at the end of SB phase were considered for double blind (DB) phase (Visit 6 to Visit 9) [13 weeks]. All subjects entered 1 week taper phase after completion. |
| Arm/Group Title | Pregabalin (Single Blind Phase) | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Period Title: Single-Blind Phase | |||
| STARTED | 441 | 0 | 0 |
| COMPLETED | 320 | 0 | 0 |
| NOT COMPLETED | 121 | 0 | 0 |
| Period Title: Single-Blind Phase | |||
| STARTED | 0 | 63 | 59 |
| Treated | 0 | 63 | 58 |
| COMPLETED | 0 | 46 | 47 |
| NOT COMPLETED | 0 | 17 | 12 |
Baseline Characteristics
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Overall Participants | 441 |
| Age, Customized (Number) [Number] | |
| <18 years |
0
0%
|
| 18 - 44 years |
178
40.4%
|
| 45 - 64 years |
227
51.5%
|
| ≥ 65 years |
36
8.2%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
392
88.9%
|
| Male |
49
11.1%
|
Outcome Measures
| Title | Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) |
|---|---|
| Description | The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase). |
| Time Frame | Randomization to Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Median (95% Confidence Interval) [Days] |
58
|
23
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0186 |
| Comments | The p-value was calculated using log-rank test for comparing pregabalin CR with placebo | |
| Method | Log Rank | |
| Comments | ||
| Title | Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event |
|---|---|
| Description | Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response. |
| Time Frame | Randomization to Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Count of Participants [Participants] |
34
7.7%
|
41
NaN
|
| Title | Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 |
|---|---|
| Description | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Baseline, Weeks 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Week 1 |
-0.9
(1.17)
|
| Week 2 |
-1.5
(1.51)
|
| Week 3 |
-2.0
(1.85)
|
| Week 4 |
-2.3
(2.01)
|
| Week 5 |
-2.5
(2.00)
|
| Week 6 |
-2.6
(2.13)
|
| Title | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
|---|---|
| Description | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Week 7 |
-3.9
(1.49)
|
-3.0
(1.59)
|
| Week 8 |
-3.7
(1.72)
|
-2.7
(1.99)
|
| Week 9 |
-3.6
(2.01)
|
-2.8
(1.91)
|
| Week 10 |
-3.7
(1.96)
|
-2.4
(2.01)
|
| Week 11 |
-3.7
(2.21)
|
-2.6
(1.94)
|
| Week 12 |
-3.7
(1.98)
|
-2.6
(1.82)
|
| Week 13 |
-3.6
(2.10)
|
-2.6
(2.21)
|
| Week 14 |
-3.5
(2.11)
|
-2.5
(2.14)
|
| Week 15 |
-3.6
(2.30)
|
-2.6
(2.24)
|
| Week 16 |
-3.4
(2.22)
|
-2.6
(1.94)
|
| Week 17 |
-3.6
(2.02)
|
-2.5
(1.82)
|
| Week 18 |
-3.4
(2.53)
|
-2.5
(1.93)
|
| Week 19 |
-3.4
(2.59)
|
-2.4
(2.11)
|
| Week 20 |
-3.0
(2.82)
|
-4.9
(2.74)
|
| Title | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit |
|---|---|
| Description | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Baseline, Double blind endpoint visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 62 | 58 |
| Least Squares Mean (95% Confidence Interval) [Units on a scale] |
-2.9
|
-2.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3310 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.4 | |
| Confidence Interval |
(2-Sided) 95% -1.2 to 0.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 |
|---|---|
| Description | The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). |
| Time Frame | Baseline, Weeks 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Week 1 |
-0.7
(1.16)
|
| Week 2 |
-1.2
(1.53)
|
| Week 3 |
-1.6
(1.91)
|
| Week 4 |
-2.0
(2.08)
|
| Week 5 |
-2.2
(2.10)
|
| Week 6 |
-2.3
(2.17)
|
| Title | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
|---|---|
| Description | The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). |
| Time Frame | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Week 7 |
-3.4
(1.74)
|
-3.0
(1.79)
|
| Week 8 |
-3.3
(1.81)
|
-2.8
(1.95)
|
| Week 9 |
-3.2
(1.93)
|
-2.9
(1.98)
|
| Week 10 |
-3.2
(2.03)
|
-2.6
(1.93)
|
| Week 11 |
-3.1
(2.16)
|
-2.5
(1.91)
|
| Week 12 |
-3.4
(1.77)
|
-2.5
(1.69)
|
| Week 13 |
-3.2
(1.82)
|
-2.6
(1.87)
|
| Week 14 |
-3.2
(2.06)
|
-2.5
(1.95)
|
| Week 15 |
-3.4
(2.15)
|
-2.6
(1.96)
|
| Week 16 |
-3.1
(2.15)
|
-2.7
(1.84)
|
| Week 17 |
-3.4
(1.88)
|
-2.5
(1.96)
|
| Week 18 |
-3.2
(2.24)
|
-2.4
(1.82)
|
| Week 19 |
-3.1
(2.23)
|
-2.4
(1.96)
|
| Week 20 |
-2.7
(2.42)
|
-4.9
(1.48)
|
| Title | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit |
|---|---|
| Description | The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). |
| Time Frame | Baseline, Double blind endpoint visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 62 | 58 |
| Least Squares Mean (95% Confidence Interval) [Units on a scale] |
-2.6
|
-2.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9247 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -0.8 to 0.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.40 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Weeks 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Subjective Wake after Sleep Onset (Week 1) |
-19.1
(45.90)
|
| Subjective Wake after Sleep Onset (Week 2) |
-22.4
(50.22)
|
| Subjective Wake after Sleep Onset (Week 3) |
-25.0
(64.57)
|
| Subjective Wake after Sleep Onset (Week 4) |
-27.5
(62.58)
|
| Subjective Wake after Sleep Onset (Week 5) |
-31.4
(57.37)
|
| Subjective Wake after Sleep Onset (Week 6) |
-32.8
(59.51)
|
| Subjective Latency to Sleep Onset (Week 1) |
-10.3
(42.35)
|
| Subjective Latency to Sleep Onset (Week 2) |
-13.0
(43.25)
|
| Subjective Latency to Sleep Onset (Week 3) |
-15.5
(49.01)
|
| Subjective Latency to Sleep Onset (Week 4) |
-19.6
(49.84)
|
| Subjective Latency to Sleep Onset (Week 5) |
-20.0
(52.32)
|
| Subjective Latency to Sleep Onset (Week 6) |
-16.9
(47.34)
|
| Title | Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Weeks 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants who awakened after sleep. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 439 |
| Subjective No.of Awakenings after Sleep (Week 1) |
-0.8
(1.28)
|
| Subjective No.of Awakenings after Sleep (Week 2) |
-1.0
(1.50)
|
| Subjective No.of Awakenings after Sleep (Week 3) |
-1.1
(1.54)
|
| Subjective No.of Awakenings after Sleep (Week 4) |
-1.1
(1.44)
|
| Subjective No.of Awakenings after Sleep (Week 5) |
-1.2
(1.70)
|
| Subjective No.of Awakenings after Sleep (Week 6) |
-1.2
(1.52)
|
| Title | Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Weeks 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Subjective Total Sleep Time (Week 1) |
0.6
(0.93)
|
| Subjective Total Sleep Time (Week 2) |
0.6
(0.96)
|
| Subjective Total Sleep Time (Week 3) |
0.6
(1.00)
|
| Subjective Total Sleep Time (Week 4) |
0.7
(0.94)
|
| Subjective Total Sleep Time (Week 5) |
0.7
(1.00)
|
| Subjective Total Sleep Time (Week 6) |
0.7
(1.08)
|
| Title | Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. |
| Time Frame | Baseline, Weeks 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 439 |
| Sleep quality (Week 1) |
1.0
(1.35)
|
| Sleep quality (Week 2) |
1.2
(1.43)
|
| Sleep quality (Week 3) |
1.5
(1.75)
|
| Sleep quality (Week 4) |
1.6
(1.79)
|
| Sleep quality (Week 5) |
1.7
(1.82)
|
| Sleep quality (Week 6) |
1.7
(1.89)
|
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Subjective Wake after Sleep Onset (Week 7) |
-27.8
(37.29)
|
-32.0
(50.47)
|
| Subjective Wake after Sleep Onset (Week 8) |
-27.4
(39.39)
|
-28.0
(56.99)
|
| Subjective Wake after Sleep Onset (Week 9) |
-27.0
(40.12)
|
-33.2
(56.45)
|
| Subjective Wake after Sleep Onset (Week 10) |
-26.9
(38.92)
|
-26.2
(68.24)
|
| Subjective Wake after Sleep Onset (Week 11) |
-29.0
(44.80)
|
-37.4
(56.79)
|
| Subjective Wake after Sleep Onset (Week 12) |
-26.0
(46.00)
|
-31.0
(43.96)
|
| Subjective Wake after Sleep Onset (Week 13) |
-22.8
(37.78)
|
-31.4
(50.08)
|
| Subjective Wake after Sleep Onset (Week 14) |
-27.0
(39.87)
|
-43.3
(54.45)
|
| Subjective Wake after Sleep Onset (Week 15) |
-31.7
(38.37)
|
-35.1
(56.47)
|
| Subjective Wake after Sleep Onset (Week 16) |
-25.9
(41.95)
|
-35.0
(52.67)
|
| Subjective Wake after Sleep Onset (Week 17) |
-31.5
(34.29)
|
-36.2
(58.67)
|
| Subjective Wake after Sleep Onset (Week 18) |
-32.4
(36.37)
|
-37.3
(56.67)
|
| Subjective Wake after Sleep Onset (Week 19) |
-27.3
(52.27)
|
-23.1
(46.28)
|
| Subjective Wake after Sleep Onset (Week 20) |
-22.5
(11.03)
|
-7.1
(11.15)
|
| Subjective Latency to Sleep Onset (Week 7) |
-15.6
(55.67)
|
-19.1
(41.02)
|
| Subjective Latency to Sleep Onset (Week 8) |
-19.1
(29.70)
|
-12.3
(42.83)
|
| Subjective Latency to Sleep Onset (Week 9) |
-18.4
(34.03)
|
-16.0
(50.97)
|
| Subjective Latency to Sleep Onset (Week 10) |
-19.5
(29.40)
|
-18.0
(43.83)
|
| Latency to Sleep Onset (Week 11) |
-18.5
(22.40)
|
-18.0
(47.82)
|
| Subjective Latency to Sleep Onset (Week 12) |
-16.3
(26.04)
|
-18.8
(40.31)
|
| Subjective Latency to Sleep Onset (Week 13) |
-17.5
(20.79)
|
-16.8
(36.51)
|
| Subjective Latency to Sleep Onset (Week 14) |
-20.8
(25.58)
|
-21.8
(44.03)
|
| Subjective Latency to Sleep Onset (Week 15) |
-19.4
(20.25)
|
-19.1
(42.55)
|
| Subjective Latency to Sleep Onset (Week 16) |
-15.8
(31.85)
|
-20.9
(42.18)
|
| Subjective Latency to Sleep Onset (Week 17) |
-23.1
(23.09)
|
-20.9
(49.30)
|
| Subjective Latency to Sleep Onset (Week 18) |
-16.3
(24.52)
|
-18.7
(46.23)
|
| Subjective Latency to Sleep Onset (Week 19) |
-16.7
(29.38)
|
-19.5
(50.89)
|
| Subjective Latency to Sleep Onset (Week 20) |
23.0
(84.31)
|
-28.7
(8.00)
|
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Subjective No.of Awakenings after Sleep (Week 7) |
-1.1
(1.39)
|
-1.0
(1.30)
|
| Subjective No.of Awakenings after Sleep (Week 8) |
-1.2
(1.23)
|
-0.8
(1.27)
|
| Subjective No.of Awakenings after Sleep (Week 9) |
-1.2
(0.94)
|
-1.1
(1.12)
|
| Subjective No.of Awakenings after Sleep (Week 10) |
-1.2
(1.10)
|
-0.9
(1.16)
|
| Subjective No.of Awakenings after Sleep (Week 11) |
-1.1
(1.40)
|
-0.9
(1.18)
|
| Subjective No.of Awakenings after Sleep (Week 12) |
-1.1
(1.50)
|
-0.8
(1.00)
|
| Subjective No.of Awakenings after Sleep (Week 13) |
-1.0
(1.02)
|
-1.0
(1.13)
|
| Subjective No.of Awakenings after Sleep (Week 14) |
-1.0
(1.06)
|
-1.1
(1.07)
|
| Subjective No.of Awakenings after Sleep (Week 15) |
-0.8
(2.20)
|
-1.1
(1.21)
|
| Subjective No.of Awakenings after Sleep (Week 16) |
-1.0
(1.10)
|
-1.0
(1.18)
|
| Subjective No.of Awakenings after Sleep (Week 17) |
-1.2
(0.92)
|
-0.9
(1.25)
|
| Subjective No.of Awakenings after Sleep (Week 18) |
-1.1
(1.14)
|
-1.0
(1.28)
|
| Subjective No.of Awakenings after Sleep (Week 19) |
-0.7
(2.63)
|
-0.9
(1.32)
|
| Subjective No.of Awakenings after Sleep (Week 20) |
-1.5
(1.14)
|
-1.5
(0.95)
|
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. |
| Time Frame | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Subjective Total Sleep Time (Week 7) |
0.7
(1.00)
|
0.5
(1.10)
|
| Subjective Total Sleep Time (Week 8) |
0.9
(0.89)
|
0.6
(1.25)
|
| Subjective Total Sleep Time (Week 9) |
0.8
(1.00)
|
0.5
(1.10)
|
| Subjective Total Sleep Time (Week 10) |
0.9
(1.07)
|
0.5
(1.01)
|
| Subjective Total Sleep Time (Week 11) |
0.9
(0.86)
|
0.6
(1.08)
|
| Subjective Total Sleep Time (Week 12) |
0.8
(1.01)
|
0.5
(1.13)
|
| Subjective Total Sleep Time (Week 13) |
0.7
(0.93)
|
0.6
(0.95)
|
| Subjective Total Sleep Time (Week 14) |
0.9
(1.31)
|
0.7
(1.17)
|
| Subjective Total Sleep Time (Week 15) |
0.7
(0.90)
|
0.7
(1.22)
|
| Subjective Total Sleep Time (Week 16) |
0.7
(0.94)
|
0.7
(1.04)
|
| Subjective Total Sleep Time (Week 17) |
0.7
(0.85)
|
0.7
(1.08)
|
| Subjective Total Sleep Time (Week 18) |
0.6
(0.85)
|
0.5
(1.23)
|
| Subjective Total Sleep Time (Week 19) |
0.5
(1.10)
|
0.6
(1.15)
|
| Subjective Total Sleep Time (Week 20) |
-0.1
(1.02)
|
0.5
(0.41)
|
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. |
| Time Frame | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Sleep Quality (Week 7) |
1.9
(1.69)
|
1.9
(1.62)
|
| Sleep Quality (Week 8) |
2.0
(1.61)
|
1.7
(1.71)
|
| Sleep Quality (Week 9) |
2.1
(1.47)
|
1.8
(1.66)
|
| Sleep Quality (Week 10) |
2.2
(1.70)
|
1.7
(1.74)
|
| Sleep Quality (Week 11) |
2.3
(1.78)
|
1.7
(1.63)
|
| Sleep Quality (Week 12) |
2.1
(1.66)
|
1.7
(1.65)
|
| Sleep Quality (Week 13) |
1.9
(1.72)
|
1.9
(1.63)
|
| Sleep Quality (Week 14) N=48,43 |
2.2
(1.69)
|
2.1
(1.73)
|
| Sleep Quality (Week 15) |
2.2
(1.76)
|
2.0
(1.64)
|
| Sleep Quality (Week 16) |
1.9
(1.87)
|
1.9
(1.68)
|
| Sleep Quality (Week 17) |
2.2
(1.71)
|
1.9
(1.72)
|
| Sleep Quality (Week 18) |
2.1
(1.64)
|
1.8
(1.71)
|
| Sleep Quality (Week 19) |
2.0
(1.77)
|
1.5
(1.55)
|
| Sleep Quality (Week 20) |
3.1
(1.23)
|
3.3
(0.45)
|
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Double blind endpoint visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 62 | 58 |
| Subjective Wake after Sleep Onset |
-26.2
|
-20.6
|
| Subjective Latency to Sleep Onset |
-10.6
|
-11.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Subjective Wake after Sleep Onset | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4314 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.6 | |
| Confidence Interval |
(2-Sided) 95% -19.7 to 8.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 7.12 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Subjective Latency to Sleep Onset | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8915 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% -17.1 to 19.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.26 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Double blind endpoint visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 62 | 58 |
| Least Squares Mean (95% Confidence Interval) [Number of times the participant awakened] |
-0.5
|
-0.8
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4571 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.3 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 1.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. |
| Time Frame | Baseline, Double blind endpoint visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 62 | 58 |
| Least Squares Mean (95% Confidence Interval) [Hours] |
0.6
|
0.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3779 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% -0.2 to 0.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit |
|---|---|
| Description | The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). |
| Time Frame | Baseline, Double blind endpoint visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 62 | 58 |
| Least Squares Mean (95% Confidence Interval) [Units on a scale] |
1.9
|
1.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2009 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% -0.2 to 1.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.34 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period) |
|---|---|
| Description | Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 289 |
| Mean (Standard Deviation) [Units on a scale] |
-1.6
(2.18)
|
| Title | Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period) |
|---|---|
| Description | Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 60 | 57 |
| Least Squares Mean (95% Confidence Interval) [Units on a scale] |
-3.1
|
-2.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1845 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.6 | |
| Confidence Interval |
(2-Sided) 95% -1.6 to 0.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.48 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II |
|---|---|
| Description | The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Sleep disturbance |
-21.8
(24.82)
|
| Snoring |
-1.0
(24.94)
|
| Awakening Short of Breath/with a Headache |
-11.0
(30.59)
|
| Sleep adequacy |
18.9
(31.17)
|
| Somnolence |
-3.6
(24.87)
|
| Sleep Problems Index I |
-16.1
(21.62)
|
| Sleep Problems Index II |
-15.9
(20.44)
|
| Title | Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep |
|---|---|
| Description | The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Mean (Standard Deviation) [hours] |
0.7
(1.33)
|
| Title | Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II |
|---|---|
| Description | The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Sleep disturbance |
-25.4
|
-15.5
|
| Snoring |
-2.4
|
-2.9
|
| Awakening Short of Breath/with a Headache |
-8.1
|
-4.2
|
| Sleep adequacy |
23.9
|
17.1
|
| Somnolence |
-11.9
|
-6.6
|
| Sleep Problems Index I |
-19.5
|
-13.7
|
| Sleep Problems Index II |
-19.7
|
-14.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Sleep disturbance | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0305 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -9.9 | |
| Confidence Interval |
(2-Sided) 95% -18.9 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.52 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Snoring | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3133 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.2 | |
| Confidence Interval |
(2-Sided) 95% -5.0 to 15.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.17 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Awakening Short of Breath or with a Headache | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2985 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.9 | |
| Confidence Interval |
(2-Sided) 95% -11.2 to 3.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.71 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Sleep adequacy | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2159 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.8 | |
| Confidence Interval |
(2-Sided) 95% -4.1 to 17.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.49 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Somnolence | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2041 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.2 | |
| Confidence Interval |
(2-Sided) 95% -13.4 to 2.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.10 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Sleep Problems Index I | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1319 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.8 | |
| Confidence Interval |
(2-Sided) 95% -13.4 to 1.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.81 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Sleep Problems Index II | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1473 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.7 | |
| Confidence Interval |
(2-Sided) 95% -13.4 to 2.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.89 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep |
|---|---|
| Description | The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Least Squares Mean (95% Confidence Interval) [hours] |
0.7
|
0.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3596 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% -0.2 to 0.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 |
|---|---|
| Description | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). |
| Time Frame | Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 289 |
| Very Much Improved |
24
5.4%
|
| Much Improved |
77
17.5%
|
| Minimally Improved |
103
23.4%
|
| No Change |
46
10.4%
|
| Minimally Worse |
16
3.6%
|
| Much Worse |
18
4.1%
|
| Very Much Worse |
5
1.1%
|
| Title | Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 |
|---|---|
| Description | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). |
| Time Frame | Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 60 | 57 |
| Very Much Improved |
7
1.6%
|
7
NaN
|
| Much Improved |
15
3.4%
|
11
NaN
|
| Minimally Improved |
14
3.2%
|
12
NaN
|
| No Change |
9
2%
|
11
NaN
|
| Minimally Worse |
7
1.6%
|
6
NaN
|
| Much Worse |
7
1.6%
|
8
NaN
|
| Very Much Worse |
1
0.2%
|
2
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin. Odds ratio > 1 is in favor of Pregabalin 330 - 495 mg/day. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4985 |
| Comments | Nominal p-value for two-sided test. | |
| Method | two-sided test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.25 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 2.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| SF-36 Physical Functioning |
14.0
(19.89)
|
| SF-36 Role-Physical |
17.8
(27.38)
|
| SF-36 Pain Index |
20.7
(22.07)
|
| SF-36 General Health Perceptions |
8.5
(17.96)
|
| SF-36 Vitality |
18.2
(24.35)
|
| SF-36 Social Functioning |
12.9
(28.19)
|
| SF-36 Role-Emotional |
8.6
(29.40)
|
| SF-36 Mental Health Index |
7.9
(18.94)
|
| Physical Component Score |
7.2
(8.75)
|
| Mental Component Score |
4.5
(11.78)
|
| Title | Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 |
|---|---|
| Description | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| SF-36 Physical Functioning |
12.4
|
13.7
|
| SF-36 Role-Physical |
18.9
|
16.2
|
| SF-36 Pain Index |
19.2
|
16.0
|
| SF-36 General Health Perceptions |
3.3
|
9.3
|
| SF-36 Vitality |
12.2
|
15.7
|
| SF-36 Social Functioning |
13.3
|
13.5
|
| SF-36 Role-Emotional |
3.8
|
2.2
|
| SF-36 Mental Health Index |
6.6
|
5.2
|
| Physical Component Score |
6.8
|
7.2
|
| Mental Component Score |
2.6
|
2.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Physical Functioning | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7400 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.4 | |
| Confidence Interval |
(2-Sided) 95% -9.5 to 6.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.10 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Role-Physical | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5938 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.6 | |
| Confidence Interval |
(2-Sided) 95% -7.1 to 12.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.89 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Pain Index | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4842 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.2 | |
| Confidence Interval |
(2-Sided) 95% -5.9 to 12.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.61 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 General Health Perceptions | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0827 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -6.1 | |
| Confidence Interval |
(2-Sided) 95% -12.9 to 0.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.45 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Vitality | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4561 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.5 | |
| Confidence Interval |
(2-Sided) 95% -12.09 to 5.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.73 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Social Functioning | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9645 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.2 | |
| Confidence Interval |
(2-Sided) 95% -8.8 to 8.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.31 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Role-Emotional | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7636 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.6 | |
| Confidence Interval |
(2-Sided) 95% -9.1 to 12.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.41 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: SF-36 Mental Health Index | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7067 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.3 | |
| Confidence Interval |
(2-Sided) 95% -5.7 to 8.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.54 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Physical Component Score | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8352 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.4 | |
| Confidence Interval |
(2-Sided) 95% -3.9 to 3.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.78 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Mental Component Score | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9347 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% -4.2 to 4.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.22 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6 |
|---|---|
| Description | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| HADS-A Anxiety scale |
-1.8
(3.47)
|
| HADS-D Depression scale |
-1.5
(3.62)
|
| Title | Double-Blind Phase: Change From Baseline in HADS Score at Week 19 |
|---|---|
| Description | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| HADS-A Anxiety scale |
-0.7
|
-1.6
|
| HADS-D Depression scale |
-1.4
|
-1.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | HADS-A Anxiety scale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1901 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 2.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.69 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | HADS-D Depression scale | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6914 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.3 | |
| Confidence Interval |
(2-Sided) 95% -1.6 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.65 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 |
|---|---|
| Description | The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Item 1: Physical activities |
-0.9
(2.14)
|
| Item 2: Feel good |
-2.2
(3.33)
|
| Item 3: Work missed |
-0.5
(2.42)
|
| Item 4: Do job |
-1.5
(2.72)
|
| Item 5: Pain |
-1.6
(2.25)
|
| Item 6: Fatigue |
-1.4
(2.43)
|
| Item 7: Rested |
-1.7
(2.65)
|
| Item 8: Stiffness |
-1.8
(2.65)
|
| Item 9: Anxiety |
-1.2
(2.95)
|
| Item 10: Depression |
-0.6
(2.75)
|
| Total Score |
-13.4
(16.71)
|
| Title | Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 |
|---|---|
| Description | The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Item 1: Physical activities |
-1.0
|
-1.3
|
| Item 2: feel good |
-3.0
|
-3.2
|
| Item 3: Work missed |
-1.2
|
-1.0
|
| Item 4: Do job |
-2.1
|
-2.2
|
| Item 5: Pain |
-2.7
|
-2.2
|
| Item 6: Fatigue |
-2.3
|
-2.4
|
| Item 7: Rested |
-2.6
|
-2.2
|
| Item 8: Stiffness |
-2.4
|
-2.2
|
| Item 9: Anxiety |
-1.8
|
-1.7
|
| Item 10: Depression |
-0.7
|
-0.7
|
| Total Score |
-19.6
|
-19.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 1: Physical activities | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3721 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 1.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.41 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 2: Feel good | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8084 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% -1.1 to 1.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.64 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 3: Work missed | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6312 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.2 | |
| Confidence Interval |
(2-Sided) 95% -0.9 to 0.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.35 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 4: Do job | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8824 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% -1.0 to 1.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.57 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 5: Pain | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2742 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.5 | |
| Confidence Interval |
(2-Sided) 95% -1.5 to 0.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.49 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 6: Fatigue | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8520 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.1 | |
| Confidence Interval |
(2-Sided) 95% -0.8 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.46 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 7: Rested | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5264 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.3 | |
| Confidence Interval |
(2-Sided) 95% -1.4 to 0.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.55 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 8: Stiffness | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6601 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.2 | |
| Confidence Interval |
(2-Sided) 95% -1.3 to 0.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.55 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 9: Anxiety | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8937 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.1 | |
| Confidence Interval |
(2-Sided) 95% -1.2 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.56 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Item 10: Depression | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9151 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.1 | |
| Confidence Interval |
(2-Sided) 95% -1.0 to 0.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.47 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the total score | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9045 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.5 | |
| Confidence Interval |
(2-Sided) 95% -8.2 to 7.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.91 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 |
|---|---|
| Description | The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| General fatigue |
-0.2
(2.47)
|
| Physical fatigue |
0.1
(2.67)
|
| Reduced activity |
-0.2
(2.55)
|
| Reduced motivation |
0.2
(2.71)
|
| Mental fatigue |
-0.1
(2.17)
|
| Title | Double-Blind Phase: Change From Baseline in MFI Score at Week 19 |
|---|---|
| Description | The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| General fatigue |
0.1
|
-0.1
|
| Physical fatigue |
-0.1
|
0.2
|
| Reduced activity |
0.0
|
-0.3
|
| Reduced motivation |
1.0
|
0.3
|
| Mental fatigue |
-0.1
|
0.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: General Fatigue | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4606 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.2 | |
| Confidence Interval |
(2-Sided) 95% -0.4 to 0.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Physical Fatigue | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4703 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.3 | |
| Confidence Interval |
(2-Sided) 95% -1.0 to 0.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.37 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Reduced activity | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4009 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.3 | |
| Confidence Interval |
(2-Sided) 95% -0.4 to 1.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Reduced motivation | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0695 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% -0.1 to 1.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.35 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Mental fatigue | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5869 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.1 | |
| Confidence Interval |
(2-Sided) 95% -0.7 to 0.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 |
|---|---|
| Description | The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. |
| Time Frame | Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Benefit from treatment-No |
69
15.6%
|
| Benefit from treatment-Little benefit |
137
31.1%
|
| Benefit from treatment-much benefit |
211
47.8%
|
| Satisfaction from treatment-very dissatisfied |
52
11.8%
|
| Satisfaction from treatment-a little dissatisfied |
59
13.4%
|
| Satisfaction from treatment-a little satisfied |
103
23.4%
|
| Satisfaction from treatment-very satisfied |
203
46%
|
| Willing to continue treatment-very unwilling |
68
15.4%
|
| Willing to continue treatment-little unwilling |
33
7.5%
|
| Willing to continue treatment-little bit willing |
49
11.1%
|
| Willing to continue treatment-very willing |
266
60.3%
|
| Title | Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 |
|---|---|
| Description | The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. |
| Time Frame | Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed"= participants evaluable for specified categories. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 57 |
| Benefit from treatment-No |
3
0.7%
|
11
NaN
|
| Benefit from treatment-Little benefit |
15
3.4%
|
16
NaN
|
| Benefit from treatment-much benefit |
41
9.3%
|
30
NaN
|
| Satisfaction from treatment-very dissatisfied |
4
0.9%
|
6
NaN
|
| Satisfaction from treatment-a little dissatisfied |
10
2.3%
|
8
NaN
|
| Satisfaction from treatment-a little satisfied |
10
2.3%
|
13
NaN
|
| Satisfaction from treatment-very satisfied |
36
8.2%
|
30
NaN
|
| Willing to continue treatment-very unwilling |
8
1.8%
|
4
NaN
|
| Willing to continue treatment-little unwilling |
6
1.4%
|
8
NaN
|
| Willing to continue treatment-little bit willing |
9
2%
|
11
NaN
|
| Willing to continue treatment-very willing |
37
8.4%
|
34
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Benefit from treatment | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0296 |
| Comments | Nominal p-value for two-sided test. | |
| Method | two-sided test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.29 | |
| Confidence Interval |
(2-Sided) 95% 1.09 to 4.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Satisfaction from treatment | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4691 |
| Comments | Nominal p-value for two-sided test | |
| Method | two-sided test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.29 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 2.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Willingness to continue treatment | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9577 |
| Comments | Nominal p-value for two-sided test | |
| Method | two-sided test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.98 | |
| Confidence Interval |
(2-Sided) 95% 0.48 to 2.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 |
|---|---|
| Description | WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. |
| Time Frame | Baseline, Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Percent Work Time Missed |
-5.8
(48.69)
|
| Percent Impairment While Working |
-10.0
(31.29)
|
| Percent Activity Impairment |
-13.5
(25.88)
|
| Percent Overall Work Impairment |
-12.3
(27.62)
|
| Title | Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 |
|---|---|
| Description | WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. |
| Time Frame | Baseline, Week 19 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Percent Work Time Missed |
-7.3
|
-26.7
|
| Percent Impairment While Working |
-14.0
|
-15.0
|
| Percent Activity Impairment |
-16.4
|
-19.6
|
| Percent Overall Work Impairment |
-15.9
|
-17.5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Percent Work Time Missed | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0562 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 19.3 | |
| Confidence Interval |
(2-Sided) 95% -0.5 to 39.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.85 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Percent Impairment While Working | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7892 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.1 | |
| Confidence Interval |
(2-Sided) 95% -7.0 to 9.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.96 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Percent Activity Impairment | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0819 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.2 | |
| Confidence Interval |
(2-Sided) 95% -0.4 to 6.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.82 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Percent Overall Work Impairment | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4135 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.6 | |
| Confidence Interval |
(2-Sided) 95% -2.2 to 5.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.91 |
|
| Estimation Comments | ||
| Title | Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. |
| Time Frame | Baseline, Weeks 3, 4, 5, 6 and 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Total Sleep Time (Week 3) |
-0.1
(0.94)
|
| Total Sleep Time (Week 4) |
0.4
(0.99)
|
| Total Sleep Time (Week 5) |
0.3
(1.02)
|
| Total Sleep Time (Week 6) |
0.3
(1.15)
|
| Total Sleep Time (Week 7) |
0.6
(1.10)
|
| Title | Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). |
| Time Frame | Baseline, Weeks 3, 4, 5, 6 and 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Minutes of Interrupted Sleep (Week 3) |
-5.3
(12.63)
|
| Minutes of Interrupted Sleep (Week 4) |
-5.9
(16.10)
|
| Minutes of Interrupted Sleep (Week 5) |
-7.0
(15.66)
|
| Minutes of Interrupted Sleep (Week 6) |
-6.6
(16.12)
|
| Minutes of Interrupted Sleep (Week 7) |
0.7
(19.43)
|
| Title | Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. |
| Time Frame | Baseline, Weeks 3, 4, 5, 6 and 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Sleep Fragmentation Index (Week 3) |
-0.8
(5.27)
|
| Sleep Fragmentation Index (Week 4) |
-2.5
(5.45)
|
| Sleep Fragmentation Index (Week 5) |
-2.8
(5.27)
|
| Sleep Fragmentation Index (Week 6) |
-2.6
(5.63)
|
| Sleep Fragmentation Index (Week 7) |
0.7
(5.85)
|
| Title | Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day. |
| Time Frame | Baseline, Weeks 3, 4, 5, 6 and 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Total daytime activity (Week 3) |
10264.3
(90090.07)
|
| Total daytime activity (Week 4) |
10588.1
(59150.38)
|
| Total daytime activity (Week 5) |
8635.8
(54823.64)
|
| Total daytime activity (Week 6) |
7134.2
(58221.22)
|
| Total daytime activity (Week 7) |
18420.7
(61725.84)
|
| Title | Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. |
| Time Frame | Baseline, Weeks 3, 4, 5, 6 and 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) |
|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. |
| Measure Participants | 441 |
| Percent Sedentary (Week 3) |
0.7
(6.66)
|
| Percent Sedentary (Week 4) |
0.7
(5.61)
|
| Percent Sedentary (Week 5) |
0.6
(5.62)
|
| Percent Sedentary (Week 6) |
0.3
(6.07)
|
| Percent Sedentary (Week 7) |
0.2
(5.51)
|
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. |
| Time Frame | Baseline, Weeks 11, 12, 13, 14 and 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Total Sleep Time (Week 11) |
0.5
(0.91)
|
0.0
(1.53)
|
| Total Sleep Time (Week 12) |
0.5
(1.23)
|
0.1
(1.01)
|
| Total Sleep Time (Week 13) |
0.4
(1.15)
|
0.1
(1.15)
|
| Total Sleep Time (Week 14) |
0.4
(1.02)
|
0.1
(1.14)
|
| Total Sleep Time (Week 15) |
0.2
(0.91)
|
0.3
(1.13)
|
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). |
| Time Frame | Baseline, Weeks 11, 12, 13, 14 and 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Minutes of Interrupted Sleep (Week 11) |
-9.0
(10.27)
|
2.5
(18.97)
|
| Minutes of Interrupted Sleep (Week 12) |
-3.0
(14.77)
|
-1.7
(14.10)
|
| Minutes of Interrupted Sleep (Week 13) |
-3.0
(20.33)
|
0.4
(14.14)
|
| Minutes of Interrupted Sleep (Week 14) |
-3.2
(19.12)
|
-1.8
(13.19)
|
| Minutes of Interrupted Sleep (Week 15) |
-0.4
(25.03)
|
-0.5
(13.73)
|
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. |
| Time Frame | Baseline, Weeks 11, 12, 13, 14 and 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Sleep Fragmentation Index (Week 11) |
-4.4
(5.53)
|
0.1
(5.17)
|
| Sleep Fragmentation Index (Week 12) |
-2.8
(5.91)
|
-0.4
(6.29)
|
| Sleep Fragmentation Index (Week 13) |
-2.2
(7.28)
|
-0.3
(5.23)
|
| Sleep Fragmentation Index (Week 14) |
-2.4
(7.32)
|
-0.6
(4.75)
|
| Sleep Fragmentation Index (Week 15) |
-0.9
(7.41)
|
-0.9
(5.19)
|
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day. |
| Time Frame | Baseline, Weeks 11, 12, 13, 14 and 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Total daytime activity (Week 11) |
-1894.1
(46879.81)
|
-2083.9
(40939.67)
|
| Total daytime activity ((Week 12) |
-50.7
(50114.87)
|
-6691.1
(47353.03)
|
| Total daytime activity ((Week 13) |
-4362.4
(51922.75)
|
521.8
(46996.71)
|
| Total daytime activity ((Week 14) |
-179.7
(55858.35)
|
-4523.8
(52629.95)
|
| Total daytime activity ((Week 15) |
-4138.3
(54924.02)
|
-4649.4
(58121.16)
|
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. |
| Time Frame | Baseline, Weeks 11, 12, 13, 14 and 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 63 | 58 |
| Percent Sedentary (Week 11) |
-0.7
(7.72)
|
1.1
(6.69)
|
| Percent Sedentary (Week 12) |
-0.8
(5.66)
|
-1.4
(6.15)
|
| Percent Sedentary (Week 13) |
-1.3
(5.41)
|
-0.9
(6.15)
|
| Percent Sedentary (Week 14) |
-2.1
(6.56)
|
-1.1
(7.27)
|
| Percent Sedentary (Week 15) |
-1.5
(5.21)
|
-1.4
(6.56)
|
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19) |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. |
| Time Frame | Baseline, Double blind end point visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 44 | 38 |
| Least Squares Mean (95% Confidence Interval) [Hours] |
0.5
|
0.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1224 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% -0.1 to 0.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.24 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19) |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). |
| Time Frame | Baseline, Double blind end point visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 44 | 38 |
| Least Squares Mean (95% Confidence Interval) [Minutes] |
-3.5
|
-2.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7680 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.2 | |
| Confidence Interval |
(2-Sided) 95% -9.3 to 6.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.06 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19) |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. |
| Time Frame | Baseline, Double blind end point visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 44 | 38 |
| Least Squares Mean (95% Confidence Interval) [Percentage of immobile bouts] |
-2.5
|
-0.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1360 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.9 | |
| Confidence Interval |
(2-Sided) 95% -4.5 to 0.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.29 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19) |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity "counts" during the day. |
| Time Frame | Baseline, Double blind end point visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 44 | 38 |
| Least Squares Mean (95% Confidence Interval) [Counts of total daytime activity] |
-182.7
|
-6672.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | This analysis is for the domain: Total daytime activity | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6077 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6489.5 | |
| Confidence Interval |
(2-Sided) 95% -18648.6 to 31627.6 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 12579.50 |
|
| Estimation Comments | ||
| Title | Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19) |
|---|---|
| Description | Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. |
| Time Frame | Baseline, Double blind end point visit (Week 19) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|
| Arm/Group Description | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 44 | 38 |
| Least Squares Mean (95% Confidence Interval) [Percent of daytime] |
-1.4
|
-2.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pregabalin (Double Blind Phase), Placebo (Double Blind Phase) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6647 |
| Comments | Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% -2.2 to 3.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.38 |
|
| Estimation Comments | ||
| Title | Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) |
|---|---|
| Description | C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. |
| Time Frame | Week 1 to Week 7 and Week 11 to Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The population in the single and double blind phase consisted of all paticipants who received at least 1 dose of study medication and who received at least 1 dose of study medication. |
| Arm/Group Title | Pregabalin (Single Blind Phase) | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) |
|---|---|---|---|
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. |
| Measure Participants | 441 | 63 | 58 |
| Week 1 |
5
1.1%
|
||
| Week 2 |
6
1.4%
|
||
| Week 3 |
4
0.9%
|
||
| Week 6 |
16
3.6%
|
||
| Week 7 |
10
2.3%
|
||
| Week 11 |
3
0.7%
|
0
NaN
|
|
| Week 15 |
1
0.2%
|
1
NaN
|
|
| Week 19 |
1
0.2%
|
3
NaN
|
|
| Week 20 |
1
0.2%
|
1
NaN
|
Adverse Events
| Time Frame | From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. | |||||
| Arm/Group Title | Pregabalin (Single Blind Phase) | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) | |||
| Arm/Group Description | Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 [Week 1], Visit 4 [Week 2], and Visit 5 [Week 3]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported. | |||
All Cause Mortality |
||||||
| Pregabalin (Single Blind Phase) | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Pregabalin (Single Blind Phase) | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/441 (1.1%) | 2/63 (3.2%) | 0/58 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Gastrointestinal disorders | ||||||
| Glossitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| General disorders | ||||||
| Chest pain | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Infections and infestations | ||||||
| Cellulitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Pneumonia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Investigations | ||||||
| Hypertension | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Breast cancer | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Psychiatric disorders | ||||||
| Post-traumatic stress disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Pregabalin (Single Blind Phase) | Pregabalin (Double Blind Phase) | Placebo (Double Blind Phase) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 353/441 (80%) | 34/63 (54%) | 27/58 (46.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Thrombocytopenia | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Neutropenia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Cardiac disorders | ||||||
| Palpitations | 5/441 (1.1%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Ear pain | 1/441 (0.2%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Hyperacusis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Vertigo | 4/441 (0.9%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Eye disorders | ||||||
| Dry eye | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Eye swelling | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Angle closure glaucoma | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Conjunctivitis allergic | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Keratitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Diplopia | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Vision blurred | 29/441 (6.6%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Visual acuity reduced | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Visual impairment | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Gastrointestinal disorders | ||||||
| Dental caries | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Gingival disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Food poisoning | 1/441 (0.2%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Gastric disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Rectal haemorrhage | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Colitis ulcerative | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Enteritis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Gastritis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Constipation | 19/441 (4.3%) | 0/63 (0%) | 0/58 (0%) | |||
| Diarrhoea | 13/441 (2.9%) | 1/63 (1.6%) | 2/58 (3.4%) | |||
| Diarrhoea haemorrhagic | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Gastrooesophageal reflux disease | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Abdominal discomfort | 1/441 (0.2%) | 0/63 (0%) | 2/58 (3.4%) | |||
| Abdominal distension | 6/441 (1.4%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Abdominal pain | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Abdominal pain lower | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Abdominal pain upper | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Abdominal tenderness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Abnormal faeces | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dyspepsia | 9/441 (2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dysphagia | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Eructation | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Faecaloma | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Flatulence | 6/441 (1.4%) | 0/63 (0%) | 0/58 (0%) | |||
| Mucous stools | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Nausea | 41/441 (9.3%) | 5/63 (7.9%) | 0/58 (0%) | |||
| Vomiting | 12/441 (2.7%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Haemorrhoids | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Hypoaesthesia oral | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Mouth ulceration | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Paraesthesia oral | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dry mouth | 25/441 (5.7%) | 0/63 (0%) | 2/58 (3.4%) | |||
| Glossodynia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Glossitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| General disorders | ||||||
| Asthenia | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Chest discomfort | 2/441 (0.5%) | 0/63 (0%) | 2/58 (3.4%) | |||
| Chest pain | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Chills | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Face oedema | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Fatigue | 42/441 (9.5%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Feeling abnormal | 17/441 (3.9%) | 2/63 (3.2%) | 0/58 (0%) | |||
| Feeling drunk | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Feeling hot | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Gait disturbance | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Generalised oedema | 2/441 (0.5%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Gravitational oedema | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Malaise | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Mucosal dryness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Non-cardiac chest pain | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Oedema | 5/441 (1.1%) | 0/63 (0%) | 0/58 (0%) | |||
| Oedema peripheral | 27/441 (6.1%) | 6/63 (9.5%) | 2/58 (3.4%) | |||
| Pain | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Sluggishness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Swelling | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Thirst | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Peripheral swelling | 10/441 (2.3%) | 0/63 (0%) | 0/58 (0%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic steatosis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Immune system disorders | ||||||
| Hypersensitivity | 1/441 (0.2%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Seasonal allergy | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Infections and infestations | ||||||
| Pertussis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Fungal infection | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Tinea pedis | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Vulvovaginal mycotic infection | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Bronchitis | 5/441 (1.1%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Cystitis | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Ear infection | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Gastroenteritis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Kidney infection | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Nasopharyngitis | 3/441 (0.7%) | 1/63 (1.6%) | 3/58 (5.2%) | |||
| Otitis media | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Pyelonephritis acute | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Rhinitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Sinusitis | 4/441 (0.9%) | 2/63 (3.2%) | 0/58 (0%) | |||
| Skin infection | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Upper respiratory tract infection | 11/441 (2.5%) | 1/63 (1.6%) | 1/58 (1.7%) | |||
| Urinary tract infection | 12/441 (2.7%) | 1/63 (1.6%) | 1/58 (1.7%) | |||
| Vulvovaginitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Gastroenteritis viral | 1/441 (0.2%) | 2/63 (3.2%) | 0/58 (0%) | |||
| Herpes simplex | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Herpes zoster | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Influenza | 1/441 (0.2%) | 1/63 (1.6%) | 1/58 (1.7%) | |||
| Viral upper respiratory tract infection | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Conjunctivitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Cellulitis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Pneumonia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Cartilage injury | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Foot fracture | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Hand fracture | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Joint injury | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Bone contusion | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Excoriation | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Fall | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Laceration | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Ligament sprain | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Muscle strain | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Overdose | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Procedural dizziness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Contusion | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Sunburn | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Investigations | ||||||
| Blood pressure diastolic increased | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Blood pressure increased | 3/441 (0.7%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Cardiac murmur | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Heart sounds abnormal | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Alanine aminotransferase increased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Aspartate aminotransferase increased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Blood cholesterol increased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Blood glucose increased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Blood uric acid increased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Bacterial test positive | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Helicobacter test positive | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Neurological examination abnormal | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Weight increased | 30/441 (6.8%) | 2/63 (3.2%) | 1/58 (1.7%) | |||
| Glucose urine present | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Blood calcium decreased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Blood potassium increased | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Food craving | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Increased appetite | 20/441 (4.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Fluid retention | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Diabetes mellitus | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Diabetes mellitus inadequate control | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 8/441 (1.8%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Arthropathy | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Joint swelling | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Osteoarthritis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Spinal osteoarthritis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Fibromyalgia | 8/441 (1.8%) | 1/63 (1.6%) | 1/58 (1.7%) | |||
| Muscle spasms | 12/441 (2.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Muscle tightness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Muscle twitching | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Muscular weakness | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Myalgia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Myokymia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Back pain | 10/441 (2.3%) | 2/63 (3.2%) | 1/58 (1.7%) | |||
| Musculoskeletal chest pain | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Musculoskeletal pain | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Musculoskeletal stiffness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Neck pain | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Pain in extremity | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Plantar fasciitis | 1/441 (0.2%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Tendon disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Arthritis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Invasive ductal breast carcinoma | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Nervous system disorders | ||||||
| Headache | 43/441 (9.8%) | 1/63 (1.6%) | 2/58 (3.4%) | |||
| Migraine | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Sinus headache | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Amnesia | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Cognitive disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Disturbance in attention | 24/441 (5.4%) | 0/63 (0%) | 0/58 (0%) | |||
| Memory impairment | 6/441 (1.4%) | 2/63 (3.2%) | 0/58 (0%) | |||
| Mental impairment | 9/441 (2%) | 0/63 (0%) | 0/58 (0%) | |||
| Bradykinesia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dyskinesia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Psychomotor hyperactivity | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Tremor | 5/441 (1.1%) | 0/63 (0%) | 0/58 (0%) | |||
| Ataxia | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Balance disorder | 19/441 (4.3%) | 0/63 (0%) | 0/58 (0%) | |||
| Coordination abnormal | 6/441 (1.4%) | 0/63 (0%) | 0/58 (0%) | |||
| Depressed level of consciousness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dizziness | 161/441 (36.5%) | 2/63 (3.2%) | 2/58 (3.4%) | |||
| Dysarthria | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Dysgeusia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Hypoaesthesia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Lethargy | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Paraesthesia | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Presyncope | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Sedation | 11/441 (2.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Sensory disturbance | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Somnolence | 105/441 (23.8%) | 0/63 (0%) | 0/58 (0%) | |||
| Hypersomnia | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Poor quality sleep | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Head discomfort | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Seizure | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Psychiatric disorders | ||||||
| Irritability | 4/441 (0.9%) | 0/63 (0%) | 0/58 (0%) | |||
| Acute stress disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Agitation | 2/441 (0.5%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Anxiety | 6/441 (1.4%) | 0/63 (0%) | 0/58 (0%) | |||
| Burnout syndrome | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Generalised anxiety disorder | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Panic attack | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Stress | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Attention deficit/hyperactivity disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Confusional state | 6/441 (1.4%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Disorientation | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Depressed mood | 1/441 (0.2%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Depression | 4/441 (0.9%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Major depression | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Bradyphrenia | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Bipolar II disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Affect lability | 2/441 (0.5%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Dysphoria | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Emotional disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Euphoric mood | 10/441 (2.3%) | 0/63 (0%) | 0/58 (0%) | |||
| Mood swings | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Aggression | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Psychiatric symptom | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Mental status changes | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Anorgasmia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Libido decreased | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Abnormal dreams | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Initial insomnia | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Insomnia | 24/441 (5.4%) | 3/63 (4.8%) | 1/58 (1.7%) | |||
| Nightmare | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Sleep disorder | 1/441 (0.2%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Somnambulism | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Post-traumatic stress disorder | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 1/441 (0.2%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Enuresis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Micturition urgency | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Pollakiuria | 3/441 (0.7%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Urinary incontinence | 3/441 (0.7%) | 0/63 (0%) | 0/58 (0%) | |||
| Urinary retention | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Breast pain | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Postmenopausal haemorrhage | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dysmenorrhoea | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Menstruation irregular | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Premenstrual syndrome | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Bronchospasm | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Cough | 5/441 (1.1%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Dry throat | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dyspnoea | 6/441 (1.4%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Dyspnoea exertional | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Oropharyngeal pain | 5/441 (1.1%) | 0/63 (0%) | 0/58 (0%) | |||
| Respiratory tract congestion | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Rhinorrhoea | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Snoring | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Epistaxis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Nasal congestion | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Nasal dryness | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Paranasal sinus hypersecretion | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Sinus congestion | 2/441 (0.5%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Swelling face | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Urticaria | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Dermal cyst | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dermatitis allergic | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dermatitis contact | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Dry skin | 2/441 (0.5%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Erythema | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Photosensitivity reaction | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Pruritus | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Rash | 5/441 (1.1%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Rash pruritic | 2/441 (0.5%) | 0/63 (0%) | 0/58 (0%) | |||
| Skin warm | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Skin hyperpigmentation | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Excessive granulation tissue | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Acne | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Alopecia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Hyperhidrosis | 2/441 (0.5%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Night sweats | 1/441 (0.2%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Onychalgia | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Ecchymosis | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
| Vascular disorders | ||||||
| Raynaud's phenomenon | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Flushing | 0/441 (0%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Hot flush | 2/441 (0.5%) | 1/63 (1.6%) | 0/58 (0%) | |||
| Phlebitis | 0/441 (0%) | 0/63 (0%) | 1/58 (1.7%) | |||
| Peripheral venous disease | 1/441 (0.2%) | 0/63 (0%) | 0/58 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT01271933
Other Study ID Numbers:
- A0081245
- FIBROMYALGIA
First Posted:
Jan 7, 2011
Last Update Posted:
Jan 22, 2021
Last Verified:
Aug 1, 2018