Diarrhea Predominant Irritable Bowel Syndrome in Females

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461526
• Other study ID #: TRN-002-202
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• crofelemer
125 mg crofelemer vs. placebo

Locations

Country	Name	City	State
United States	Akron Gastroenterology Associates, Inc.	Akron	Ohio
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Anderson Gastroenterology Associates, LLC	Anderson	South Carolina
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	Austin Gastroenterology, PA	Austin	Texas
United States	Boulder Medical Center, PC	Boulder	Colorado
United States	Consultants of Clinical Research of South Florida	Boynton Beach	Florida
United States	Radiant Research	Chandler	Arizona
United States	ClinSearch	Chattanooga	Tennessee
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Research Solutions Corp.	Cincinnati	Ohio
United States	Digestive and Liver Disease Consultants, PC	Clive	Iowa
United States	Trinity Clinic - Corsicana	Corsicana	Texas
United States	Gastrointestinal & Liver Disease Consultants	Dayton	Ohio
United States	University Clinical Research - DeLand	DeLand	Florida
United States	Gastroenterology Center of the MidSouth, PC	Germantown	Tennessee
United States	Memphis Gastroenterology Group	Germantown	Tennessee
United States	LeBauer Research Associates, PA	Greensboro	North Carolina
United States	Vital re:Search	Greensboro	North Carolina
United States	Bethany Medical Center	High Point	North Carolina
United States	Clinical Research Associates, LLC	Huntsville	Alabama
United States	Gastroenterology Associates	Jackson	Mississippi
United States	The Jackson Clinic	Jackson	Tennessee
United States	Gastroenterology Associates	Kingsport	Tennessee
United States	Maryland Digestive Disease Research	Laurel	Maryland
United States	Trover Center for Clinical Studies	Madisonville	Kentucky
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Vantage Clinical Research Group	Olympia	Washington
United States	Advanced Clinical Research Institute	Orange	California
United States	Community Clinical Trials	Orange	California
United States	Toby Village Office Park	Pittsford	New York
United States	Medical Associates Research Group	San Diego	California
United States	Grand View Medical Research	Sellersville	Pennsylvania
United States	Northside Internal Medicine	Spokane	Washington
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Stedman Clinical Trials	Tampa	Florida
United States	Rocky Mountain Gastroenterology Associates	Thornton	Colorado
United States	Litchfield County Gastroenterology Associates, LLC	Torrington	Connecticut
United States	Genova Clinical Research	Tucson	Arizona
United States	Washington Gastroenterology, PC	Washington	District of Columbia
United States	Hanover Medical Specialist, PA	Wilmington	North Carolina
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.		March 2008
Primary	To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.		March 2008