CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 197 enrolled
Drug / intervention
Pregabalin +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.

Search/NCT01432236
NCT01432236Phase 3Completed
CompareCT.gov

A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275)

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 12, 2011·Updated Jan 22, 2021

In Brief

A Phase 3 clinical trial evaluating Pregabalin and placebo for Fibromyalgia. Completed, enrolled 197 participants across 37 sites in 4 countries.

Detailed Summary

The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesCanada, Italy, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 12, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.8 years ago

Interventions

Pregabalindrug

Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose

placebodrug

placebo capsules twice a day for 14 weeks