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NCT00314249 · ClinicalTrials.gov registry record · Phase 3
Study of Milnacipran for the Treatment of Fibromyalgia
A Phase 3 study of Fibromyalgia, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,025
- Enrollment target
- 20
- Study locations
NCT00314249: Completed Phase 3 study of Fibromyalgia, sponsored by Forest Laboratories.
NCT00314249 is a Phase 3 study of Fibromyalgia that has completed, run by Forest Laboratories. The registered enrollment target is 1,025 participants, above the 166-participant average among 76 other Fibromyalgia trials with a reported enrollment target (517% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00314249, a Phase 3 study of Fibromyalgia, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,025 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Milnacipran 100mg
Study Locations (20)
California
- Forest Investigative Site - Fresno
- Forest Investigative Site - Pismo Beach
- Forest Investigative Site - Vista
Florida
- Forest Investigative Site - St. Petersburg
- Forest Investigative Site - St. Petersburg
- Forest Investigative Site - Stuart
Ohio
- Forest Investigative Site - Cleveland
- Forest Investigative Site - Columbus
- Forest Investigative Site - Toledo
Massachusetts
- Forest Investigative Site - Springfield
- Forest Investigative Site - Worcester
New York
- Forest Investigative Site - Johnson City
- Forest Investigative Site - Syracuse
Alabama
- Forest Investigative Site - Tuscaloosa
Georgia
- Forest Investigative Site - Atlanta
Nebraska
- Forest Investigative Site - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,025 participants |
| Start Date | 2006-04 |
| Phase | Phase 3 |
What the finished NCT00314249 record still lists
NCT00314249 is an interventional study that assigns participants to a tested intervention. Its 1,025 participants enrollment target places it among the larger protocols in the corpus, above the 166-participant average among 76 other Fibromyalgia trials with a reported enrollment target (517% higher).
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00314249 names 20 study sites across 12 states, led by California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT00314249 about?
NCT00314249 is a clinical study titled "Study of Milnacipran for the Treatment of Fibromyalgia". 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.
What is the current status of trial NCT00314249?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,025 participants. The study started on 2006-04.
What conditions does trial NCT00314249 study?
This clinical trial studies the following conditions: Fibromyalgia.
What interventions are being tested in trial NCT00314249?
The interventions under investigation include: Placebo (DRUG), Milnacipran 100mg (DRUG).
Who is sponsoring clinical trial NCT00314249?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00314249 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00314249's enrollment target sits among peer trials
1,025 2nd of 76 the highest of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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