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Completed

NCT Number: NCT00101725

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

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).

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Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastrointestinal Disease Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Associates, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Crofelemer

Drug

Primary outcomes

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

Secondary outcomes

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

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)

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 13, 2005
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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