CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 747 enrolled
Drug / intervention
pregabalin +3 moredrug
Likely dose
Pregabalin 300–600 mg daily in divided doses (twice daily)AI-extracted
Key inclusion· 3
  • ✓Diagnosis of fibromyalgia by ACR (American College of Rheumatology) criteria
  • ✓Pain Visual Analog Scale (VAS) score ≥40 mm
  • ✓Average daily pain score ≥4 on 4-item pain diary
Key exclusion· 3
  • ✕Other severe pain conditions
  • ✕Severe depression
  • ✕Concurrent use of excluded medications

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00333866
NCT00333866Phase 3Completed
CompareCT.gov

A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jun 6, 2006·Updated Feb 11, 2021

In Brief

A Phase 3 clinical trial evaluating pregabalin and placebo for Fibromyalgia. Completed, enrolled 747 participants across 74 sites in 16 countries.

Detailed Summary

This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesAustralia, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2006
Enrollment StartJul 1, 2006
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.1 years ago

Interventions

pregabalindrug

600mg/day

pregabalindrug

450mg/day

pregabalindrug

300mg/day

placebodrug

placebo