Status:
COMPLETED
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With 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
This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Eligibility Criteria
Inclusion
- ACR criteria for fibromyalgia
- A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries
Exclusion
- Patients with other severe pain conditions
- Patients with severe depression
- Patients taking excluded medications
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
747 Patients enrolled
Trial Details
Trial ID
NCT00333866
Start Date
July 1 2006
End Date
November 1 2007
Last Update
February 11 2021
Active Locations (74)
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1
Pfizer Investigational Site
Warrawong, New South Wales, Australia, 2502
2
Pfizer Investigational Site
Maroochydore, Queensland, Australia, 4558
3
Pfizer Investigational Site
Clayton, Victoria, Australia, 3168
4
Pfizer Investigational Site
Fitzroy, Victoria, Australia, 3065