Clinical trial NCT00101725: A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Colonic Diseases
Diarrhea
Gastrointestinal Disease
Keywords: Diarrhea
IBS
Irritable Bowel Syndrome
Abdominal pain
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2005-01-13
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Secondary outcomes:
measure: To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Chandler
country: United States
facility: Radiant Research Phoenix Southeast
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Anaheim
country: United States
facility: AGMG Clinical Research Institute
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: AGMG Clinical Research
state: California
city: San Diego
country: United States
facility: Institute of Healthcare Assessment, Inc.
state: California
city: Washington
country: United States
facility: Washington Gastroenterology
state: District of Columbia
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: University Clinical Research DeLand
state: Florida
city: Peoria
country: United States
facility: nTouch Research
state: Illinois
city: Saginaw
country: United States
facility: Synergy Medical Education Alliance
state: Michigan
city: Jackson
country: United States
facility: CRC of Jakson
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Medical Group
state: Missouri
city: Pittsford
country: United States
facility: Tobey 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: Medoff Medical / Vital Research
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Assoc., Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Radient Research
state: Ohio
city: Sellersville
country: United States
facility: Grandview Medical Research, Inc
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Gastroenterology
state: South Carolina
city: Bristol
country: United States
facility: TriCities Medical Research
state: Tennessee
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: Memphis
country: United States
facility: Memphis Gastroenterology
state: Tennessee
city: Dallas
country: United States
facility: Radiant Research Dallas-North
state: Texas
city: Tacoma
country: United States
facility: Tacoma Digestive Disease Research Center
state: Washington
Study officials:
References: