Diarrhea Predominant Irritable Bowel Syndrome in Females

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) in Females

Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)

The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. 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 will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks.

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

Participants must meet all of the following criteria:

  • Females at least 18 years of age
  • 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 in the past 5 years.
  • Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

  • Serious medical or surgical conditions
  • Colon Cancer, Crohns Disease or Ulcerative Colitis
  • Pregnant or breast feeding

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)

The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. 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 will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks.

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

Participants must meet all of the following criteria:

  • Females at least 18 years of age
  • 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 in the past 5 years.
  • Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

  • Serious medical or surgical conditions
  • Colon Cancer, Crohns Disease or Ulcerative Colitis
  • Pregnant or breast feeding

Study Type

Interventional

Enrollment (Actual)

240

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

    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates, LLC
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Radiant Research
      • Tucson, Arizona, United States, 85741
        • Genova Clinical Research
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • Orange, California, United States, 92869
        • Advanced Clinical Research Institute
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Boulder Medical Center, PC
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Gastroenterology Associates
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Litchfield County Gastroenterology Associates, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Gastroenterology, PC
    • Florida
      • Boynton Beach, Florida, United States, 33436
        • Consultants of Clinical Research of South Florida
      • DeLand, Florida, United States, 32720
        • University Clinical Research - DeLand
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Mount Vernon Clinical Research
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Iowa
      • Clive, Iowa, United States, 50325
        • Digestive and Liver Disease Consultants, PC
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Trover Center for Clinical Studies
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Maryland Digestive Disease Research
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Gastroenterology Associates
    • New York
      • Pittsford, New York, United States, 14534
        • Toby Village Office Park
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • LeBauer Research Associates, PA
      • Greensboro, North Carolina, United States, 27408
        • Vital re:Search
      • High Point, North Carolina, United States, 27262
        • Bethany Medical Center
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialist, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates
    • Ohio
      • Akron, Ohio, United States, 44302
        • Akron Gastroenterology Associates, Inc.
      • Cincinnati, Ohio, United States, 45220
        • Research Solutions Corp.
      • Dayton, Ohio, United States, 45440
        • Gastrointestinal & Liver Disease Consultants
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
    • Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Grand View Medical Research
    • South Carolina
      • Anderson, South Carolina, United States, 39621
        • Anderson Gastroenterology Associates, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • ClinSearch
      • Germantown, Tennessee, United States, 37138
        • Gastroenterology Center of the MidSouth, PC
      • Germantown, Tennessee, United States, 38138
        • Memphis Gastroenterology Group
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic
      • Kingsport, Tennessee, United States, 37660
        • Gastroenterology Associates
    • Texas
      • Austin, Texas, United States, 78745
        • Austin Gastroenterology, PA
      • Corsicana, Texas, United States, 75110
        • Trinity Clinic - Corsicana
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
    • Washington
      • Olympia, Washington, United States, 98506
        • Vantage Clinical Research Group
      • Spokane, Washington, United States, 99208
        • Northside Internal Medicine

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

Female

Description

Inclusion Criteria:

  • Females at least 18 years of age
  • 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 in the past 5 years.
  • Willingness to take an approved method of birth control (if required)

Exclusion Criteria:

  • Serious medical or surgical conditions
  • Colon Cancer, Crohns Disease or Ulcerative Colitis
  • Pregnant 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
125 mg crofelemer vs. placebo
Experimental: 125 mg crofelemer
125 mg crofelemer vs. placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Time Frame: March 2008
March 2008
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Time Frame: March 2008
March 2008

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

October 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 18, 2007

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

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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