A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Phase 2

Completed

• Conditions: Gastrointestinal Disease; Irritable Bowel Syndrome; Colonic Diseases; Diarrhea
• Interventions: Drug: crofelemer

• Registration Number: NCT00101725
• Lead Sponsor: Bausch Health Americas, Inc.

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 will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.

The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-01-12
• Study First Submitted QC: 2005-01-12
• Study First Posted: 2005-01-13
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	crofelemer	-
500 mg crofelemer	crofelemer	-
250 mg crofelemer	crofelemer	-
125 mg crofelemer	crofelemer	-

Primary Outcome Measures

Name	Time	Method
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.

Trial Locations

Locations (29)

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

Radiant Research Phoenix Southeast; 🇺🇸 Chandler, Arizona, United States

Arkansas Gastroenterology; 🇺🇸 North Little Rock, Arkansas, United States

AGMG Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Community Clinical Trials; 🇺🇸 Orange, California, United States

AGMG Clinical Research; 🇺🇸 Orange, California, United States

Institute of Healthcare Assessment, Inc.; 🇺🇸 San Diego, California, United States

Washington Gastroenterology; 🇺🇸 Washington, District of Columbia, United States

Consultants for Clinical Research of South Florida; 🇺🇸 Boynton Beach, Florida, United States

University Clinical Research DeLand; 🇺🇸 DeLand, Florida, United States

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