NCT00441766

Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Allergan · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	AGN 203818	Part A: 3 mg AGN203818 capsule every 12 hours for 4 weeks
DRUG	AGN 203818	Part A: 20 mg AGN203818 capsule every 12 hours for 4 weeks
DRUG	AGN 203818	Part A: 60 mg AGN203818 capsule every 12 hours for 4 weeks
DRUG	placebo	Part A: placebo capsule every 12 hours for 4 weeks

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-03-01
• Last updated: 2012-01-20
• Results posted: 2012-01-20

Locations

1 site across 1 country: United States