- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00461526
Diarrhea Predominant Irritable Bowel Syndrome in Females
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN-002 (Crofelemer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS) in Females
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
Study Overview
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35801
- Clinical Research Associates, LLC
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Arizona
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Chandler, Arizona, United States, 85225
- Radiant Research
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Tucson, Arizona, United States, 85741
- Genova Clinical Research
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California
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Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
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Orange, California, United States, 92868
- Community Clinical Trials
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Orange, California, United States, 92869
- Advanced Clinical Research Institute
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San Diego, California, United States, 92123
- Medical Associates Research Group
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Colorado
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Boulder, Colorado, United States, 80304
- Boulder Medical Center, PC
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Thornton, Colorado, United States, 80229
- Rocky Mountain Gastroenterology Associates
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Connecticut
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Torrington, Connecticut, United States, 06790
- Litchfield County Gastroenterology Associates, LLC
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Gastroenterology, PC
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Florida
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Boynton Beach, Florida, United States, 33436
- Consultants of Clinical Research of South Florida
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DeLand, Florida, United States, 32720
- University Clinical Research - DeLand
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Tampa, Florida, United States, 33613
- Stedman Clinical Trials
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Georgia
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Atlanta, Georgia, United States, 30328
- Mount Vernon Clinical Research
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Stockbridge, Georgia, United States, 30281
- Clinical Research Atlanta
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Iowa
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Clive, Iowa, United States, 50325
- Digestive and Liver Disease Consultants, PC
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Kentucky
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Madisonville, Kentucky, United States, 42431
- Trover Center for Clinical Studies
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Maryland
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Laurel, Maryland, United States, 20707
- Maryland Digestive Disease Research
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Mississippi
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Jackson, Mississippi, United States, 39202
- Gastroenterology Associates
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New York
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Pittsford, New York, United States, 14534
- Toby Village Office Park
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North Carolina
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Greensboro, North Carolina, United States, 27403
- LeBauer Research Associates, PA
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Greensboro, North Carolina, United States, 27408
- Vital re:Search
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High Point, North Carolina, United States, 27262
- Bethany Medical Center
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Wilmington, North Carolina, United States, 28401
- Hanover Medical Specialist, PA
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Winston-Salem, North Carolina, United States, 27103
- Piedmont Medical Research Associates
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Ohio
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Akron, Ohio, United States, 44302
- Akron Gastroenterology Associates, Inc.
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Cincinnati, Ohio, United States, 45220
- Research Solutions Corp.
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Dayton, Ohio, United States, 45440
- Gastrointestinal & Liver Disease Consultants
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Foundation for Digestive Research
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Oklahoma City, Oklahoma, United States, 73112
- Sooner Clinical Research
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Pennsylvania
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Sellersville, Pennsylvania, United States, 18960
- Grand View Medical Research
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South Carolina
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Anderson, South Carolina, United States, 39621
- Anderson Gastroenterology Associates, LLC
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- ClinSearch
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Germantown, Tennessee, United States, 37138
- Gastroenterology Center of the MidSouth, PC
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Germantown, Tennessee, United States, 38138
- Memphis Gastroenterology Group
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Jackson, Tennessee, United States, 38301
- The Jackson Clinic
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Kingsport, Tennessee, United States, 37660
- Gastroenterology Associates
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Texas
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Austin, Texas, United States, 78745
- Austin Gastroenterology, PA
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Corsicana, Texas, United States, 75110
- Trinity Clinic - Corsicana
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Virginia
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Chesapeake, Virginia, United States, 23320
- Gastroenterology Associates of Tidewater
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Washington
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Olympia, Washington, United States, 98506
- Vantage Clinical Research Group
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Spokane, Washington, United States, 99208
- Northside Internal Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion 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)
Exclusion Criteria:
- Serious medical or surgical conditions
- Colon Cancer, Crohns Disease or Ulcerative Colitis
- Pregnant or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: placebo
|
125 mg crofelemer vs. placebo
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Experimental: 125 mg crofelemer
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125 mg crofelemer vs. placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Time Frame: March 2008
|
March 2008
|
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Time Frame: March 2008
|
March 2008
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRN-002-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
-
Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
-
University of ViennaCompleted
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Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
-
GlaxoSmithKlineCompletedIrritable Bowel Syndrome (IBS) | Irritable ColonUnited States
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
Clinical Trials on crofelemer
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Shaman PharmaceuticalsCompleted
-
Bausch Health Americas, Inc.CompletedHIV Associated DiarrheaUnited States, Puerto Rico
-
Bausch Health Americas, Inc.CompletedHIV Enteropathy | Diarrhea With HIVUnited States
-
Bausch Health Americas, Inc.CompletedIrritable Bowel Syndrome | Colonic Diseases | Diarrhea | Gastrointestinal DiseaseUnited States
-
Beth Israel Deaconess Medical CenterTerminated
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Napo Pharmaceuticals, Inc.Active, not recruitingAdult Solid Tumor | Cancer Therapy-Related Diarrhea | Chemotherapy-related Diarrhea | Prophylaxis of Diarrhea | Symptomatic Relief of Diarrhea | Targeted Therapy-related DiarrheaUnited States, Taiwan, Georgia, Serbia, Argentina
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Sandra SwainGenentech, Inc.; Medstar Health Research Institute; Lombardi Comprehensive Cancer... and other collaboratorsCompletedDiarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients (HALT-D)Breast CancerUnited States
-
Shaman PharmaceuticalsCompletedHIV Infections | Herpes SimplexUnited States
-
Lindsey Russell, MDNapo Pharmaceuticals, Inc.Not yet recruitingShort Bowel SyndromeUnited States
-
Shaman PharmaceuticalsCompletedHIV Infections | Herpes SimplexUnited States, Puerto Rico