A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101725
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : November 22, 2010
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease Drug: crofelemer Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : December 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Crofelemer

Arm Intervention/treatment
Experimental: 125 mg crofelemer Drug: crofelemer
Experimental: 250 mg crofelemer Drug: crofelemer
Experimental: 500 mg crofelemer Drug: crofelemer
Placebo Comparator: placebo Drug: crofelemer

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101725

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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.

Responsible Party: Michelle Widmann, Salix Pharmaceuticals Identifier: NCT00101725     History of Changes
Other Study ID Numbers: TRN 002 201
First Posted: January 13, 2005    Key Record Dates
Last Update Posted: November 22, 2010
Last Verified: November 2010

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Irritable Bowel Syndrome
Abdominal pain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Intestinal Diseases