A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.

Official Title
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A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Pregabalin
* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2) Exclusion Criteria: Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders Patients with severe depression

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: A<br> | Drug: Pregabalin<br>* Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).<br>|
| Experimental: B<br> | Drug: Pregabalin<br>* Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).<br>|
| Experimental: C<br> | Drug: Pregabalin<br>* Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).<br>|
| Placebo Comparator: D<br> | Drug: Placebo<br>* Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint mean pain score derived from the subject's daily pain diary |  | Endpoint | 
| Patient Global Assessment (Patient Global Impression of Change) at Termination Visit |  | Weeks 5 and 13 | 
| Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit |  | Baseline and Weeks 5, 9, and 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in FIQ scores at Weeks 5, 9, and 13 |  | Baseline and Weeks 5, 9, and 13 | 
| Change from baseline in SDS scores at Weeks 5, 9, and 13 |  | Baseline and Weeks 5, 9, and 13 | 
| Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13 |  | Baseline and Weeks 5, 9, and 13 | 
| Quality of Sleep Score from the Daily Sleep Diary |  | Daily | 
| Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13 |  | Baseline and Weeks 5, 9, and 13 | 
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13 |  | Baseline and Week 13 | 
| Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13 |  | Screening, baseline, and Weeks 5, 9, and 13 | 
| Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13 |  | Baseline and Weeks 9 and 13 | 
| Adverse events |  | Weeks 1, 2, 5, 9, 13, and at follow-up | 
| Physical examination, including vital signs and weight |  | Baseline and Week 5 (vital signs only) and 13 | 
| Neurological examination |  | Screening and Week 13 | 
| Electrocardiogram |  | Screening and Week 13 | 
| Laboratory tests, including chemistry and hematology |  | Baseline and Weeks 5, 13, and at follow-up | 
| Urinalysis |  | Baseline and Weeks 13 and at follow-up |