A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00101725

Collaborator

(none)

245

Enrollment

Locations

Arms

Duration (Months)

8.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Dec 1, 2004

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Arms and Interventions

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

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Associates	Huntsville	Alabama	United States	35801
2	Radiant Research Phoenix Southeast	Chandler	Arizona	United States	85225
3	Arkansas Gastroenterology	North Little Rock	Arkansas	United States	72117
4	AGMG Clinical Research Institute	Anaheim	California	United States	92801
5	Community Clinical Trials	Orange	California	United States	92868
6	AGMG Clinical Research	Orange	California	United States	92869
7	Institute of Healthcare Assessment, Inc.	San Diego	California	United States	92120
8	Washington Gastroenterology	Washington	District of Columbia	United States	20010
9	Consultants for Clinical Research of South Florida	Boynton Beach	Florida	United States	33426
10	University Clinical Research DeLand	DeLand	Florida	United States	32720
11	nTouch Research	Peoria	Illinois	United States	61602
12	Synergy Medical Education Alliance	Saginaw	Michigan	United States	48602
13	CRC of Jakson	Jackson	Mississippi	United States	39202
14	Mercy Medical Group	Saint Louis	Missouri	United States	63141
15	Tobey Village Office Park	Pittsford	New York	United States	14534
16	LeBauer Research Associates, PA	Greensboro	North Carolina	United States	27403
17	Medoff Medical / Vital Research	Greensboro	North Carolina	United States	27408
18	Hanover Medical Specialists, PA	Wilmington	North Carolina	United States	28401
19	Piedmont Medical Research Assoc., Inc.	Winston-Salem	North Carolina	United States	27103
20	Consultants for Clinical Research	Cincinnati	Ohio	United States	45219
21	Radient Research	Columbus	Ohio	United States	43212
22	Grandview Medical Research, Inc	Sellersville	Pennsylvania	United States	18960
23	Anderson Gastroenterology	Anderson	South Carolina	United States	29621
24	TriCities Medical Research	Bristol	Tennessee	United States	37620
25	ClinSearch	Chattanooga	Tennessee	United States	37404
26	Jackson Clinic	Jackson	Tennessee	United States	38301
27	Memphis Gastroenterology	Memphis	Tennessee	United States	38120
28	Radiant Research Dallas-North	Dallas	Texas	United States	75231
29	Tacoma Digestive Disease Research Center	Tacoma	Washington	United States	98405