A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).

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

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.

Criteria

Inclusion Criteria:

• Diagnosis of diarrhea predominant Irritable Bowel Syndrome

• Willingness to make daily calls on a touch-tone telephone

• Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not received one since your IBS diagnosis and in the past 5 years

• Willingness to use an approved method of birth control

Exclusion Criteria:

• Serious medical or surgical conditions

• Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis

• Pregnancy or breast feeding