drugset / Trial / NCT00314249
Study of Milnacipran for the Treatment of Fibromyalgia
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-04
- Primary completion
- 2008-06
- Completion
- —
Outcome
Met primary endpoint
registry Placebo vs Milnacipran; p <0.001; Odds Ratio (OR) 2.06 (95% CI 1.45 to 2.94) NCT00314249 ↗
registry Placebo vs Milnacipran; p <0.001; Odds Ratio (OR) 1.86 (95% CI 1.38 to 2.51) NCT00314249 ↗
Publications
- Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.
- Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Milnacipran | Other / unclassified | 100 mg | Oral |