A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
- Conditions
- Gastrointestinal DiseaseIrritable Bowel SyndromeColonic DiseasesDiarrhea
- Interventions
- Registration Number
- NCT00101725
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- 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
- Serious medical or surgical conditions
- Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- Pregnancy or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo crofelemer - 500 mg crofelemer crofelemer - 250 mg crofelemer crofelemer - 125 mg crofelemer crofelemer -
- Primary Outcome Measures
Name Time Method To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
- Secondary Outcome Measures
Name Time Method To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Trial Locations
- Locations (29)
AGMG Clinical Research Institute
🇺🇸Anaheim, California, United States
LeBauer Research Associates, PA
🇺🇸Greensboro, North Carolina, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Radiant Research Phoenix Southeast
🇺🇸Chandler, Arizona, United States
Institute of Healthcare Assessment, Inc.
🇺🇸San Diego, California, United States
Synergy Medical Education Alliance
🇺🇸Saginaw, Michigan, United States
nTouch Research
🇺🇸Peoria, Illinois, United States
Tobey Village Office Park
🇺🇸Pittsford, New York, United States
Medoff Medical / Vital Research
🇺🇸Greensboro, North Carolina, United States
Hanover Medical Specialists, PA
🇺🇸Wilmington, North Carolina, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Radient Research
🇺🇸Columbus, Ohio, United States
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Radiant Research Dallas-North
🇺🇸Dallas, Texas, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Memphis Gastroenterology
🇺🇸Memphis, Tennessee, United States
Washington Gastroenterology
🇺🇸Washington, District of Columbia, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Consultants for Clinical Research of South Florida
🇺🇸Boynton Beach, Florida, United States
University Clinical Research DeLand
🇺🇸DeLand, Florida, United States
Anderson Gastroenterology
🇺🇸Anderson, South Carolina, United States
TriCities Medical Research
🇺🇸Bristol, Tennessee, United States
CRC of Jakson
🇺🇸Jackson, Mississippi, United States
Mercy Medical Group
🇺🇸Saint Louis, Missouri, United States
Tacoma Digestive Disease Research Center
🇺🇸Tacoma, Washington, United States
Grandview Medical Research, Inc
🇺🇸Sellersville, Pennsylvania, United States
Piedmont Medical Research Assoc., Inc.
🇺🇸Winston-Salem, North Carolina, United States
Community Clinical Trials
🇺🇸Orange, California, United States
AGMG Clinical Research
🇺🇸Orange, California, United States