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NCT00101725 Clinical Trial

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 (Crofelemer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00101725
Other study ID # TRN 002 201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2004
Est. completion date November 2005

Study information
Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• crofelemer

Locations
Country Name City State
United States AGMG Clinical Research Institute Anaheim California
United States Anderson Gastroenterology Anderson South Carolina
United States Consultants for Clinical Research of South Florida Boynton Beach Florida
United States TriCities Medical Research Bristol Tennessee
United States Radiant Research Phoenix Southeast Chandler Arizona
United States ClinSearch Chattanooga Tennessee
United States Consultants for Clinical Research Cincinnati Ohio
United States Radient Research Columbus Ohio
United States Radiant Research Dallas-North Dallas Texas
United States University Clinical Research DeLand DeLand Florida
United States LeBauer Research Associates, PA Greensboro North Carolina
United States Medoff Medical / Vital Research Greensboro North Carolina
United States Clinical Research Associates Huntsville Alabama
United States CRC of Jakson Jackson Mississippi
United States Jackson Clinic Jackson Tennessee
United States Memphis Gastroenterology Memphis Tennessee
United States Arkansas Gastroenterology North Little Rock Arkansas
United States AGMG Clinical Research Orange California
United States Community Clinical Trials Orange California
United States nTouch Research Peoria Illinois
United States Tobey Village Office Park Pittsford New York
United States Synergy Medical Education Alliance Saginaw Michigan
United States Mercy Medical Group Saint Louis Missouri
United States Institute of Healthcare Assessment, Inc. San Diego California
United States Grandview Medical Research, Inc Sellersville Pennsylvania
United States Tacoma Digestive Disease Research Center Tacoma Washington
United States Washington Gastroenterology Washington District of Columbia
United States Hanover Medical Specialists, PA Wilmington North Carolina
United States Piedmont Medical Research Assoc., Inc. Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Secondary To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
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