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NCT Number: NCT00461526

Diarrhea Predominant Irritable Bowel Syndrome 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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Associates, LLC, Huntsville, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crofelemer

Drug

125 mg crofelemer vs. placebo

Primary outcomes

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

    Time frame: March 2008

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

    Time frame: March 2008

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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) in Females

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 18, 2007
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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