Diarrhea Predominant Irritable Bowel Syndrome in Females
- Registration Number
- NCT00461526
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- 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)
- Serious medical or surgical conditions
- Colon Cancer, Crohns Disease or Ulcerative Colitis
- Pregnant or breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo crofelemer - 125 mg crofelemer crofelemer -
- Primary Outcome Measures
Name Time Method To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. March 2008 To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. March 2008
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
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
🇺🇸Orange, California, United States
Community Clinical Trials
🇺🇸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, District of Columbia, United States
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