A Study of Crofelmer to Treat Diarrhea Irritable Bowel Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

January 12, 2005

Last Updated Date

October 31, 2005

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00101725 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Crofelmer to Treat Diarrhea Irritable Bowel Syndrome

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 (Crofelmer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)

Brief Summary

This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelmer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).

Detailed Description

The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be adminstered 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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Irritable Bowel Syndrome
Colonic Diseases
Diarrhea
Gastrointestinal Disease

Intervention ^ICMJE

Drug: crofelmer

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

240

Completion Date

November 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00101725

Responsible Party

Study ID Numbers ^ICMJE

TRN 002 201, TRN 002 201

Study Sponsor ^ICMJE

Trine Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

David Rosenbaum, PhD

Trine Pharmaceuticals

Information Provided By

Trine Pharmaceuticals

Verification Date

August 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP