A Safety Study Of Pregabalin In Fibromyalgia
Phase 3
Completed
- Conditions
- Fibromyalgia
- Registration Number
- NCT00282997
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To evaluate the safety of pregabalin in patients with fibromyalgia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Patients must meet the 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 must complete the double-blind study.
Exclusion Criteria
- Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the safety of pregabalin in patients with fibromyalgia
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain pregabalin's efficacy in fibromyalgia pain modulation?
How does pregabalin compare to SNRI medications in managing fibromyalgia symptoms and sleep disturbances?
Are there specific biomarkers associated with improved safety outcomes in pregabalin-treated fibromyalgia patients?
What are the most common adverse events reported in phase 3 pregabalin trials for chronic pain conditions?
How do gabapentinoids like pregabalin and gabapentin differ in their therapeutic approaches to fibromyalgia?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Milwaukee, Wisconsin, United States
Pfizer Investigational Site🇺🇸Milwaukee, Wisconsin, United States