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

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

Purpose

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).

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Colonic Diseases Diarrhea

U.S. FDA Resources

Further study details as provided by Trine 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.

Estimated Enrollment:	240
Study Start Date:	December 2004
Estimated Study Completion Date:	November 2005

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.

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

Trine Pharmaceuticals

Investigators

Study Director:

David Rosenbaum, PhD

Trine Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	TRN 002 201, TRN 002 201
Study First Received:	January 12, 2005
Last Updated:	October 31, 2005
ClinicalTrials.gov Identifier:	NCT00101725 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Trine Pharmaceuticals:

Diarrhea
IBS
Irritable Bowel Syndrome
Abdominal pain

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Syndrome
Irritable Bowel Syndrome
Colonic Diseases
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on November 30, 2009