CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,025 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Milnacipran 100mgfrom 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/NCT00314249
NCT00314249Phase 3Completed
CompareCT.gov

A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.

Forest Laboratories·interventional·Posted Apr 13, 2006·Updated Jan 20, 2010

In Brief

A Phase 3 clinical trial evaluating Placebo and Milnacipran 100mg for Fibromyalgia. Completed, enrolled 1,025 participants across 24 sites.

Detailed Summary

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsCypress Bioscience, Inc.

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 13, 2006
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.2 years ago

Interventions

Placebodrug

Placebo, oral administration, twice daily for 12 weeks

Milnacipran 100mgdrug

Milnacipran 100mg per day (50mg BID \[twice a day\])