Status:
COMPLETED
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Irritable Bowel Syndrome
Colonic Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered orally twice a day. Subjects who are eligible to participate wil...
Eligibility Criteria
Inclusion
- 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
- Serious medical or surgical conditions
- Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- Pregnancy or breast feeding
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00101725
Start Date
December 1 2004
End Date
November 1 2005
Last Update
November 25 2019
Active Locations (29)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
Radiant Research Phoenix Southeast
Chandler, Arizona, United States, 85225
3
Arkansas Gastroenterology
North Little Rock, Arkansas, United States, 72117
4
AGMG Clinical Research Institute
Anaheim, California, United States, 92801