Diarrhea Predominant Irritable Bowel Syndrome in Females

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00461526

Collaborator

(none)

240

Enrollment

Locations

Arms

Duration (Months)

5.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)

The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. 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 will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks.

The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis.

Participants must meet all of the following criteria:

Females at least 18 years of age
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 in the past 5 years.
Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

Serious medical or surgical conditions
Colon Cancer, Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Drug: crofelemer	Phase 2

Detailed Description

Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS)

Participants must meet all of the following criteria:

Females at least 18 years of age
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 in the past 5 years.
Willingness to take an approved method of birth control (if required)

Participants CANNOT meet any of the following criteria:

Serious medical or surgical conditions
Colon Cancer, Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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) in Females

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 125 mg crofelemer	Drug: crofelemer 125 mg crofelemer vs. placebo
Placebo Comparator: placebo	Drug: crofelemer 125 mg crofelemer vs. placebo

Arm

Intervention/Treatment

Experimental: 125 mg crofelemer

Drug: crofelemer

125 mg crofelemer vs. placebo

Placebo Comparator: placebo

Drug: crofelemer

125 mg crofelemer vs. placebo

Outcome Measures

Primary Outcome Measures

To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. [March 2008]
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. [March 2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Females at least 18 years of age
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 in the past 5 years.
Willingness to take an approved method of birth control (if required)

Exclusion Criteria:

Serious medical or surgical conditions
Colon Cancer, Crohns Disease or Ulcerative Colitis
Pregnant or breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Associates, LLC	Huntsville	Alabama	United States	35801
2	Radiant Research	Chandler	Arizona	United States	85225
3	Genova Clinical Research	Tucson	Arizona	United States	85741
4	Advanced Clinical Research Institute	Anaheim	California	United States	92801
5	Community Clinical Trials	Orange	California	United States	92868
6	Advanced Clinical Research Institute	Orange	California	United States	92869
7	Medical Associates Research Group	San Diego	California	United States	92123
8	Boulder Medical Center, PC	Boulder	Colorado	United States	80304
9	Rocky Mountain Gastroenterology Associates	Thornton	Colorado	United States	80229
10	Litchfield County Gastroenterology Associates, LLC	Torrington	Connecticut	United States	06790
11	Washington Gastroenterology, PC	Washington	District of Columbia	United States	20010
12	Consultants of Clinical Research of South Florida	Boynton Beach	Florida	United States	33436
13	University Clinical Research - DeLand	DeLand	Florida	United States	32720
14	Stedman Clinical Trials	Tampa	Florida	United States	33613
15	Mount Vernon Clinical Research	Atlanta	Georgia	United States	30328
16	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
17	Digestive and Liver Disease Consultants, PC	Clive	Iowa	United States	50325
18	Trover Center for Clinical Studies	Madisonville	Kentucky	United States	42431
19	Maryland Digestive Disease Research	Laurel	Maryland	United States	20707
20	Gastroenterology Associates	Jackson	Mississippi	United States	39202
21	Toby Village Office Park	Pittsford	New York	United States	14534
22	LeBauer Research Associates, PA	Greensboro	North Carolina	United States	27403
23	Vital re:Search	Greensboro	North Carolina	United States	27408
24	Bethany Medical Center	High Point	North Carolina	United States	27262
25	Hanover Medical Specialist, PA	Wilmington	North Carolina	United States	28401
26	Piedmont Medical Research Associates	Winston-Salem	North Carolina	United States	27103
27	Akron Gastroenterology Associates, Inc.	Akron	Ohio	United States	44302
28	Research Solutions Corp.	Cincinnati	Ohio	United States	45220
29	Gastrointestinal & Liver Disease Consultants	Dayton	Ohio	United States	45440
30	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma	United States	73104
31	Sooner Clinical Research	Oklahoma City	Oklahoma	United States	73112
32	Grand View Medical Research	Sellersville	Pennsylvania	United States	18960
33	Anderson Gastroenterology Associates, LLC	Anderson	South Carolina	United States	39621
34	ClinSearch	Chattanooga	Tennessee	United States	37404
35	Gastroenterology Center of the MidSouth, PC	Germantown	Tennessee	United States	37138
36	Memphis Gastroenterology Group	Germantown	Tennessee	United States	38138
37	The Jackson Clinic	Jackson	Tennessee	United States	38301
38	Gastroenterology Associates	Kingsport	Tennessee	United States	37660
39	Austin Gastroenterology, PA	Austin	Texas	United States	78745
40	Trinity Clinic - Corsicana	Corsicana	Texas	United States	75110
41	Gastroenterology Associates of Tidewater	Chesapeake	Virginia	United States	23320
42	Vantage Clinical Research Group	Olympia	Washington	United States	98506
43	Northside Internal Medicine	Spokane	Washington	United States	99208