A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

November 21, 2019 updated by: Bausch Health Americas, Inc.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Radiant Research Phoenix Southeast
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Anaheim, California, United States, 92801
        • AGMG Clinical Research Institute
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • Orange, California, United States, 92869
        • AGMG Clinical Research
      • San Diego, California, United States, 92120
        • Institute of HealthCare Assessment, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Gastroenterology
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Consultants for Clinical Research of South Florida
      • DeLand, Florida, United States, 32720
        • University Clinical Research Deland
    • Illinois
      • Peoria, Illinois, United States, 61602
        • nTouch Research
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Synergy Medical Education Alliance
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • CRC of Jakson
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Medical Group
    • New York
      • Pittsford, New York, United States, 14534
        • Tobey Village Office Park
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • LeBauer Research Associates, PA
      • Greensboro, North Carolina, United States, 27408
        • Medoff Medical / Vital Research
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialists, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Assoc., Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Columbus, Ohio, United States, 43212
        • Radient Research
    • Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Grandview Medical Research, Inc
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Anderson Gastroenterology
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Tricities Medical Research
      • Chattanooga, Tennessee, United States, 37404
        • ClinSearch
      • Jackson, Tennessee, United States, 38301
        • Jackson Clinic
      • Memphis, Tennessee, United States, 38120
        • Memphis Gastroenterology
    • Texas
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas-North
    • Washington
      • Tacoma, Washington, United States, 98405
        • Tacoma Digestive Disease Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: crofelemer
Experimental: 125 mg crofelemer
Drug: crofelemer
Experimental: 250 mg crofelemer
Drug: crofelemer
Experimental: 500 mg crofelemer
Drug: crofelemer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.

Secondary Outcome Measures

Outcome Measure
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

January 12, 2005

First Submitted That Met QC Criteria

January 12, 2005

First Posted (Estimate)

January 13, 2005

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRN 002 201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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