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
1 other identifier
interventional
240
1 country
43
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
April 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedNovember 25, 2019
November 1, 2019
1.2 years
November 9, 2006
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
March 2008
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
March 2008
Study Arms (2)
125 mg crofelemer
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Clinical Research Associates, LLC
Huntsville, Alabama, 35801, United States
Radiant Research
Chandler, Arizona, 85225, United States
Genova Clinical Research
Tucson, Arizona, 85741, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Community Clinical Trials
Orange, California, 92868, United States
Advanced Clinical Research Institute
Orange, California, 92869, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Boulder Medical Center, PC
Boulder, Colorado, 80304, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, 80229, United States
Litchfield County Gastroenterology Associates, LLC
Torrington, Connecticut, 06790, United States
Washington Gastroenterology, PC
Washington D.C., District of Columbia, 20010, United States
Consultants of Clinical Research of South Florida
Boynton Beach, Florida, 33436, United States
University Clinical Research - DeLand
DeLand, Florida, 32720, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Digestive and Liver Disease Consultants, PC
Clive, Iowa, 50325, United States
Trover Center for Clinical Studies
Madisonville, Kentucky, 42431, United States
Maryland Digestive Disease Research
Laurel, Maryland, 20707, United States
Gastroenterology Associates
Jackson, Mississippi, 39202, United States
Toby Village Office Park
Pittsford, New York, 14534, United States
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403, United States
Vital re:Search
Greensboro, North Carolina, 27408, United States
Bethany Medical Center
High Point, North Carolina, 27262, United States
Hanover Medical Specialist, PA
Wilmington, North Carolina, 28401, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Akron Gastroenterology Associates, Inc.
Akron, Ohio, 44302, United States
Research Solutions Corp.
Cincinnati, Ohio, 45220, United States
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio, 45440, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Grand View Medical Research
Sellersville, Pennsylvania, 18960, United States
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, 39621, United States
ClinSearch
Chattanooga, Tennessee, 37404, United States
Gastroenterology Center of the MidSouth, PC
Germantown, Tennessee, 37138, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
Gastroenterology Associates
Kingsport, Tennessee, 37660, United States
Austin Gastroenterology, PA
Austin, Texas, 78745, United States
Trinity Clinic - Corsicana
Corsicana, Texas, 75110, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Vantage Clinical Research Group
Olympia, Washington, 98506, United States
Northside Internal Medicine
Spokane, Washington, 99208, United States
Related Publications (1)
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.
PMID: 31800542DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2006
First Posted
April 18, 2007
Study Start
October 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
November 25, 2019
Record last verified: 2019-11