Diarrhea Predominant Irritable Bowel Syndrome in Females

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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

Key facts

Study ID

NCT00461526

Run by

Bausch Health Americas, Inc.

People needed

240

Starts

2006-10-01

Expected to finish

2007-12-01

Last updated by the study team

2019-11-25

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• Serious medical or surgical conditions
• Colon Cancer, Crohns Disease or Ulcerative Colitis
• Pregnant or breast feeding

Where it is running

• Clinical Research Associates, LLC — Huntsville, Alabama, United States
• Radiant Research — Chandler, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Community Clinical Trials — Orange, California, United States
• Advanced Clinical Research Institute — Orange, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Boulder Medical Center, PC — Boulder, Colorado, United States
• Rocky Mountain Gastroenterology Associates — Thornton, Colorado, United States
• Litchfield County Gastroenterology Associates, LLC — Torrington, Connecticut, United States
• Washington Gastroenterology, PC — Washington D.C., District of Columbia, United States
• Consultants of Clinical Research of South Florida — Boynton Beach, Florida, United States
• University Clinical Research - DeLand — DeLand, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Mount Vernon Clinical Research — Atlanta, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Digestive and Liver Disease Consultants, PC — Clive, Iowa, United States
• Trover Center for Clinical Studies — Madisonville, Kentucky, United States
• Maryland Digestive Disease Research — Laurel, Maryland, United States
• Gastroenterology Associates — Jackson, Mississippi, United States
• Toby Village Office Park — Pittsford, New York, 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
• Hanover Medical Specialist, PA — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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