NCT00445705

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Allergan · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	placebo	Part A: Placebo every 12 hours for 4 weeks
DRUG	AGN 203818	Part A: AGN 203818 3 mg every 12 hours for 4 weeks
DRUG	AGN 203818	Part A: AGN 203818 20 mg every 12 hours for 4 weeks
DRUG	AGN 203818	Part A: AGN 203818 60 mg every 12 hours for 4 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-03-09
• Last updated: 2015-09-07
• Results posted: 2012-01-20

Locations

3 sites across 3 countries: United States, Switzerland, United Kingdom