A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome - Full Text View

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00101725

Purpose

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	Intervention	Phase
Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease	Drug: crofelemer	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Colonic Diseases Diarrhea

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	245
Study Start Date:	December 2004
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 125 mg crofelemer	Drug: crofelemer
Experimental: 250 mg crofelemer	Drug: crofelemer
Experimental: 500 mg crofelemer	Drug: crofelemer
Placebo Comparator: placebo	Drug: crofelemer

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101725

Show 29 Study Locations

Sponsors and Collaborators

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Michelle Widmann, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00101725 History of Changes
Other Study ID Numbers:	TRN 002 201
Study First Received:	January 12, 2005
Last Updated:	November 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

Diarrhea
IBS
Irritable Bowel Syndrome
Abdominal pain

Additional relevant MeSH terms:

Colonic Diseases
Diarrhea
Gastrointestinal Diseases
Irritable Bowel Syndrome
Intestinal Diseases

Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on February 12, 2012