Status:
COMPLETED
Randomized, Double-Blind, Placebo-Controlled Study 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 15 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 VAS
- 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
- Patients with suicidality
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT00830167
Start Date
March 1 2009
End Date
May 1 2011
Last Update
January 25 2021
Active Locations (35)
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1
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
2
Pfizer Investigational Site
Ichihara-shi, Chiba, Japan
3
Pfizer Investigational Site
Yotukaidou, Chiba, Japan
4
Pfizer Investigational Site
Matuyama-si, Ehime, Japan