At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 106 enrolled
Drug / intervention
pregabalin (Lyrica)drug
Likely dose
pregabalin (Lyrica) 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.
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For 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 pregabalin (Lyrica) for Fibromyalgia. Completed, enrolled 106 participants across 19 sites.
Detailed Summary
This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartJul 2009
Primary CompletionFeb 2011
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartJul 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.4 years ago
Interventions
pregabalin (Lyrica)drug
Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks