drugset / Trial / NCT00445705
Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Outcome not reported
Stopped: “This study was terminated early due to company decision. Part B was never conducted.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REZATOMIDINE | Small molecule | 3 mg | — |
| Subject | REZATOMIDINE | Small molecule | 20 mg | — |
| Subject | REZATOMIDINE | Small molecule | 60 mg | — |