Diarrhea Predominant Irritable Bowel Syndrome in Females

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) in Females

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

• NCT number: NCT00461526
• Study type: Interventional
• Source: Bausch Health Americas, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Completion date: December 2007