A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

This study has been completed.

Sponsor:

Information provided by:

Salix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00101725

First received: January 12, 2005

Last updated: November 19, 2010

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2005
Last Updated Date	November 19, 2010
Start Date ^ICMJE	December 2004
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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 (submitted: June 23, 2005)	To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Crofelemer 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 (Crofelemer) 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 (crofelemer) 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 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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease
Intervention ^ICMJE	Drug: crofelemer
Study Arm (s)	Experimental: 125 mg crofelemer Intervention: Drug: crofelemer Experimental: 250 mg crofelemer Intervention: Drug: crofelemer Experimental: 500 mg crofelemer Intervention: Drug: crofelemer Placebo Comparator: placebo Intervention: Drug: crofelemer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	245
Completion Date	November 2005
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
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	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00101725
Other Study ID Numbers ^ICMJE	TRN 002 201
Has Data Monitoring Committee	No
Responsible Party	Michelle Widmann, Salix Pharmaceuticals
Study Sponsor ^ICMJE	Salix Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Salix Pharmaceuticals
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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