A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
- Registration Number
- NCT00645398
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 751
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D Placebo - A Pregabalin - B Pregabalin - C Pregabalin -
- Primary Outcome Measures
Name Time Method 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 Patient Global Assessment (Patient Global Impression of Change) at Termination Visit Weeks 5 and 13 Endpoint mean pain score derived from the subject's daily pain diary Endpoint
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Yakima, Washington, United States