Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

Inclusion Criteria:

• Diagnosis of fibromyalgia syndrome

• Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

• Any other uncontrolled disease

• Pregnant or nursing females