Trials / Completed
CompletedNCT00314249
Study of Milnacipran for the Treatment of Fibromyalgia
A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,025 (actual)
- Sponsor
- Forest Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo, oral administration, twice daily for 12 weeks |
| DRUG | Milnacipran 100mg | Milnacipran 100mg per day (50mg BID \[twice a day\]) |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-06-01
- First posted
- 2006-04-13
- Last updated
- 2010-01-20
- Results posted
- 2009-11-02
Locations
24 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00314249. Inclusion in this directory is not an endorsement.