Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
| Status: | Terminated |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | March 2007 |
| End Date: | January 2008 |
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.
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.
Inclusion Criteria:
- Diagnosis of fibromyalgia syndrome
- Moderate or severe pain associated with fibromyalgia
Exclusion Criteria:
- Any other uncontrolled disease
- Pregnant or nursing females
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