Clinical trial NCT00461526: Diarrhea Predominant Irritable Bowel Syndrome in Females
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: IBS
d-IBS
Irritable Bowel Syndrome
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
timeFrame: March 2008
measure: To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
timeFrame: March 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates, LLC
state: Alabama
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: Advanced Clinical Research Institute
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Boulder
country: United States
facility: Boulder Medical Center, PC
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Torrington
country: United States
facility: Litchfield County Gastroenterology Associates, LLC
state: Connecticut
city: Washington
country: United States
facility: Washington Gastroenterology, PC
state: District of Columbia
city: Boynton Beach
country: United States
facility: Consultants of Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: University Clinical Research - DeLand
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Clive
country: United States
facility: Digestive and Liver Disease Consultants, PC
state: Iowa
city: Madisonville
country: United States
facility: Trover Center for Clinical Studies
state: Kentucky
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Jackson
country: United States
facility: Gastroenterology Associates
state: Mississippi
city: Pittsford
country: United States
facility: Toby Village Office Park
state: New York
city: Greensboro
country: United States
facility: LeBauer Research Associates, PA
state: North Carolina
city: Greensboro
country: United States
facility: Vital re:Search
state: North Carolina
city: High Point
country: United States
facility: Bethany Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialist, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Akron
country: United States
facility: Akron Gastroenterology Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Research Solutions Corp.
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal & Liver Disease Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Sellersville
country: United States
facility: Grand View Medical Research
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Gastroenterology Associates, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth, PC
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology, PA
state: Texas
city: Corsicana
country: United States
facility: Trinity Clinic - Corsicana
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Olympia
country: United States
facility: Vantage Clinical Research Group
state: Washington
city: Spokane
country: United States
facility: Northside Internal Medicine
state: Washington
Study officials:
References:
citation: Nee J, Salley K, Ludwig AG, Sommers T, Ballou S, Takazawa E, Duehren S, Singh P, Iturrino J, Katon J, Lee HN, Rangan V, Lembo AJ. Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2019 Dec;10(12):e00110. doi: 10.14309/ctg.0000000000000110.