Status:
COMPLETED
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT00645398
Start Date
September 1 2004
End Date
June 1 2005
Last Update
January 25 2021
Active Locations (102)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
2
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
3
Pfizer Investigational Site
Paradise Valley, Arizona, United States, 85253
4
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023