Overview

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

Status:
Terminated
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Criteria
Inclusion Criteria:

- Diagnosis of Irritable Bowel Syndrome

- Moderate or severe IBS pain

Exclusion Criteria:

- Any other uncontrolled disease

- Pregnant or nursing females