A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
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)
1 other identifier
interventional
245
1 country
29
Brief Summary
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2004
Shorter than P25 for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 12, 2005
CompletedFirst Posted
Study publicly available on registry
January 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedNovember 25, 2019
November 1, 2019
11 months
January 12, 2005
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Secondary Outcomes (1)
To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Study Arms (4)
125 mg crofelemer
EXPERIMENTAL250 mg crofelemer
EXPERIMENTAL500 mg crofelemer
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 since your IBS diagnosis and in the past 5 years
- Willingness to use an approved method of birth control
You may not qualify if:
- Serious medical or surgical conditions
- Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Radiant Research Phoenix Southeast
Chandler, Arizona, 85225, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
AGMG Clinical Research Institute
Anaheim, California, 92801, United States
Community Clinical Trials
Orange, California, 92868, United States
AGMG Clinical Research
Orange, California, 92869, United States
Institute of Healthcare Assessment, Inc.
San Diego, California, 92120, United States
Washington Gastroenterology
Washington D.C., District of Columbia, 20010, United States
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, 33426, United States
University Clinical Research DeLand
DeLand, Florida, 32720, United States
nTouch Research
Peoria, Illinois, 61602, United States
Synergy Medical Education Alliance
Saginaw, Michigan, 48602, United States
CRC of Jakson
Jackson, Mississippi, 39202, United States
Mercy Medical Group
St Louis, Missouri, 63141, United States
Tobey Village Office Park
Pittsford, New York, 14534, United States
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403, United States
Medoff Medical / Vital Research
Greensboro, North Carolina, 27408, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401, United States
Piedmont Medical Research Assoc., Inc.
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Radient Research
Columbus, Ohio, 43212, United States
Grandview Medical Research, Inc
Sellersville, Pennsylvania, 18960, United States
Anderson Gastroenterology
Anderson, South Carolina, 29621, United States
TriCities Medical Research
Bristol, Tennessee, 37620, United States
ClinSearch
Chattanooga, Tennessee, 37404, United States
Jackson Clinic
Jackson, Tennessee, 38301, United States
Memphis Gastroenterology
Memphis, Tennessee, 38120, United States
Radiant Research Dallas-North
Dallas, Texas, 75231, United States
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 12, 2005
First Posted
January 13, 2005
Study Start
December 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
November 25, 2019
Record last verified: 2019-11