A Study For Pregabalin In Patients With Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

Official Title
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A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: pregabalin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, at least 18 years of age Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS) At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4 Exclusion Criteria: Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1) Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders CLcr less than 60 mL/min (estimated from serum creatinine)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br> | Drug: pregabalin<br>* Pregabalin capsule, 300-450mg/day, twice daily<br>|
| Placebo Comparator: Placebo<br>Matched placebo | Drug: placebo<br>* Placebo, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1. | Baseline, Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. | Week 14 | 
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment. | Baseline, Week 14 | 
| Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder. | Baseline, Week 14 | 
| Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated 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) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated 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) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated 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) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated 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) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute. | Baseline, Week 14 | 
| Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated 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) as well as a 9-item overall sleep problems index. | Baseline, Week 14 | 
| Change From Baseline in Mean Sleep Interference Score at Week 14 | The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes [unable to sleep due to pain]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO) | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO) | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO) | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST) | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. | Baseline, Week 14 | 
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14 | The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score | The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score | The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status. | Baseline, Week 14 | 
| Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14 | The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 no pain to 100 worst possible pain. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score | The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment. | Baseline, Week 14 | 
| Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score | The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment. | Baseline, Week 14 | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs. | Baseline to Follow up (Day 105) | 
| Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function. | Baseline to Follow up (Day 105) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregabalin, fibromyalgia