Diarrhea Predominant Irritable Bowel Syndrome in Females
NCT ID: NCT00461526
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2006-10-31
2007-12-31
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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125 mg crofelemer
crofelemer
125 mg crofelemer vs. placebo
placebo
crofelemer
125 mg crofelemer vs. placebo
Interventions
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crofelemer
125 mg crofelemer vs. placebo
Eligibility Criteria
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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 in the past 5 years.
* Willingness to take an approved method of birth control (if required)
Exclusion Criteria
* Colon Cancer, Crohns Disease or Ulcerative Colitis
* Pregnant or breast feeding
18 Years
FEMALE
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Salix Pharmaceuticals
Locations
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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
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Akron Gastroenterology Associates, Inc.
Akron, Ohio, United States
Research Solutions Corp.
Cincinnati, Ohio, United States
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Grand View Medical Research
Sellersville, Pennsylvania, United States
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, United States
ClinSearch
Chattanooga, Tennessee, United States
Gastroenterology Center of the MidSouth, PC
Germantown, Tennessee, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
The Jackson Clinic
Jackson, Tennessee, United States
Gastroenterology Associates
Kingsport, Tennessee, United States
Austin Gastroenterology, PA
Austin, Texas, United States
Trinity Clinic - Corsicana
Corsicana, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Vantage Clinical Research Group
Olympia, Washington, United States
Northside Internal Medicine
Spokane, Washington, United States
Countries
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References
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Nee J, Salley K, Ludwig AG, Sommers T, Ballou S, Takazawa E, Duehren S, Singh P, Iturrino J, Katon J, Lee HN, Rangan V, Lembo AJ. Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2019 Dec;10(12):e00110. doi: 10.14309/ctg.0000000000000110.
Other Identifiers
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TRN-002-202
Identifier Type: -
Identifier Source: org_study_id
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