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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
441
controlled release tablet; 165-495 mg/day; given once daily
matching placebo tablet; given once daily
Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)
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
Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event
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
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at 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).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6
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
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
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit
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)
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Andrew O. Schreiber, MD
Orange, California, United States
Apex Research Institute
Santa Ana, California, United States
Paddock Park Clinical Research
Ocala, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
Meridien Research
Tampa, Florida, United States
Arthritis Care Center
Moline, Illinois, United States
Davis Clinic, Inc
Indianapolis, Indiana, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Boston Clinical Trials
Boston, Massachusetts, United States
...and 42 more locations
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at 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).
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6
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
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
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit
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)
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
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
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at 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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at 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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at 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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 5, 6
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
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
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
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
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
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
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
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
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
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)
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit
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)
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit
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)
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit
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)
Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)
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
Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)
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
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
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
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep
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
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
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
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep
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
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at 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).
Time frame: Week 6
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at 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).
Time frame: Week 19
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at 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.
Time frame: Baseline, Week 6
Double-Blind Phase: Change From Baseline in SF-36 Score at 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.
Time frame: Baseline, Week 19
Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at 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.
Time frame: Baseline, Week 6
Double-Blind Phase: Change From Baseline in HADS Score at 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.
Time frame: Baseline, Week 19
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at 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.
Time frame: Baseline, Week 6
Double-Blind Phase: Change From Baseline in FIQ Score at 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.
Time frame: Baseline, Week 19
Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 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.
Time frame: Baseline, Week 6
Double-Blind Phase: Change From Baseline in MFI Score at 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.
Time frame: Baseline, Week 19
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at 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.
Time frame: Week 6
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at 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.
Time frame: Week 19
Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at 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.
Time frame: Baseline, Week 6
Double-Blind Phase: Change From Baseline WPAI Questionnaire at 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.
Time frame: Baseline, Week 19
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at 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.
Time frame: Baseline, Double blind end point visit (Week 19)