drugset / Trial / NCT00190866
Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
RandomizedParallel-groupDouble-blindTreatment
Summary
To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.
Timeline
- Start
- 2005-06
- Primary completion
- —
- Completion
- 2007-06
Publications
- Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.
- Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 60 mg | — |
| Subject | Duloxetine | Small molecule | 120 mg | — |