At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 357 enrolled
Drug / intervention
Pregabalindrug
Likely dose
Pregabalin 600mgfrom 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 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jun 29, 2006·Updated Jan 22, 2021
In Brief
A Phase 3 clinical trial evaluating Pregabalin for Fibromyalgia. Completed, enrolled 357 participants across 51 sites in 12 countries.
Detailed Summary
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesCanada, Denmark, France, Germany, India, Italy, Netherlands, Portugal, South Korea, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2006
Enrollment StartDec 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedJun 29, 2006
Enrollment StartDec 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.0 years ago
Interventions
Pregabalindrug
150 to 600mg/day