At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 441 enrolled
Drug / intervention
pregabalin +1 moredrug
Likely dose
pregabalin 495 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 7, 2011·Updated Jan 22, 2021
In Brief
A Phase 3 clinical trial evaluating pregabalin and placebo for Fibromyalgia. Completed, enrolled 441 participants across 52 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesCanada, India, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartMar 2011
Primary CompletionJul 2012
TodayJul 2026
First PostedJan 7, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.5 years ago
Interventions
pregabalindrug
controlled release tablet; 165-495 mg/day; given once daily
placebodrug
matching placebo tablet; given once daily