At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 107 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
pregabalin (Lyrica) 450mgfrom 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 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) 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 placebo and pregabalin (Lyrica) for Fibromyalgia. Completed, enrolled 107 participants across 36 sites in 4 countries.
Detailed Summary
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesCzechia, India, Taiwan, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartMay 2010
Primary CompletionDec 2014
TodayJul 2026
First PostedNov 25, 2009
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 16.6 years ago
Interventions
placebodrug
matching placebo capsules twice daily.
pregabalin (Lyrica)drug
75-450mg/day pregabalin dose optimised at start of study