A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome, Colonic Diseases, Diarrhea, Gastrointestinal Disease

In brief

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).

Key facts

Study ID

NCT00101725

Run by

Bausch Health Americas, Inc.

People needed

245

Starts

2004-12-01

Expected to finish

2005-11-01

Last updated by the study team

2019-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Serious medical or surgical conditions
• Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
• Pregnancy or breast feeding

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Radiant Research Phoenix Southeast — Chandler, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• AGMG Clinical Research Institute — Anaheim, California, United States
• Community Clinical Trials — Orange, California, United States
• AGMG Clinical Research — Orange, California, United States
• Institute of Healthcare Assessment, Inc. — San Diego, California, United States
• Washington Gastroenterology — Washington D.C., District of Columbia, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• University Clinical Research DeLand — DeLand, Florida, United States
• nTouch Research — Peoria, Illinois, United States
• Synergy Medical Education Alliance — Saginaw, Michigan, United States
• CRC of Jakson — Jackson, Mississippi, United States
• Mercy Medical Group — St Louis, Missouri, United States
• Tobey Village Office Park — Pittsford, New York, United States
• LeBauer Research Associates, PA — Greensboro, North Carolina, United States
• Medoff Medical / Vital Research — Greensboro, North Carolina, United States
• Hanover Medical Specialists, PA — Wilmington, North Carolina, United States
• Piedmont Medical Research Assoc., Inc. — Winston-Salem, North Carolina, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• Radient Research — Columbus, Ohio, United States
• Grandview Medical Research, Inc — Sellersville, Pennsylvania, United States
• Anderson Gastroenterology — Anderson, South Carolina, United States
• TriCities Medical Research — Bristol, Tennessee, United States
• ClinSearch — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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