At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 63 enrolled
Drug / intervention
pregabalindrug
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.
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Nov 25, 2009·Updated Jan 28, 2021
In Brief
A Phase 4 clinical trial evaluating pregabalin for Fibromyalgia. Completed, enrolled 63 participants across 26 sites in 3 countries.
Detailed Summary
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesCzechia, India, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartSep 2010
Primary CompletionJun 2015
TodayJul 2026
First PostedNov 25, 2009
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.6 years ago
Interventions
pregabalindrug
Oral capsule 75-450 mg/day