At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 498 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Pregabalin 450 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.
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 27, 2009·Updated Jan 25, 2021
In Brief
A Phase 3 clinical trial evaluating Placebo and Pregabalin for Fibromyalgia. Completed, enrolled 498 participants across 35 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartMar 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.4 years ago
Interventions
Placebodrug
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Pregabalindrug
Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)