Not Signed In -
Irritable Bowel Syndrome |
Irritable Bowel Syndrome (IBS); Spastic Colon |
Clinical Trial: A Study of Crofelmer to Treat Diarrhea Irritable Bowel Syndrome
This study is currently recruiting patients.
|
Purpose
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelmer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease | Drug: crofelmer | Phase II |
MedlinePlus related topics: Colonic Diseases; Diarrhea; Digestive Diseases; Irritable Bowel Syndrome
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 (crofelmer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)
Secondary Outcomes: To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
Expected Total Enrollment: 240
Study start: December 2004; Expected completion: January 2006
Last follow-up: November 2005; Data entry closure: December 2005
The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be adminstered orally twice a day. Subjects who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration is 16 weeks.
The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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 since your IBS diagnosis and in the past 5 years
- Willingness to use an approved method of birth control
Exclusion Criteria:
- Serious medical or surgical conditions
- Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
- Pregnancy or breast feeding
Location and Contact Information
Alabama
Clinical Research Associates, Huntsville, Alabama, 35801, United States; Recruiting
C. Allen Goetsch, MD, Principal Investigator
Arizona
Radiant Research Phoenix Southeast, Chandler, Arizona, 85225, United States; Recruiting
Randall Severance, MD, Principal Investigator
Arkansas
Arkansas Gastroenterology, North Little Rock, Arkansas, 72117, United States; Recruiting
Gary M Barton, MD, Principal Investigator
California
AGMG Clinical Research, Orange, California, 92869, United States; Recruiting
Steven Duckor, MD, Principal Investigator
Institute of Healthcare Assessment, Inc., San Diego, California, 92120, United States; Recruiting
Donald Lipkis, MD, Principal Investigator
AGMG Clinical Research Institute, Anaheim, California, 92801, United States; Recruiting
Dennis Riff, MD, Principal Investigator
Community Clinical Trials, Orange, California, 92868, United States; Recruiting
David B. Stanton, MD, Principal Investigator
District of Columbia
Washington Gastroenterology, Washington, District of Columbia, 20010, United States; Recruiting
Julio A. Salcedo, MD, Principal Investigator
Florida
Consultants for Clinical Research of South Florida, Boynton Beach, Florida, 33426, United States; Recruiting
Madeleine DuPree, MD, Principal Investigator
University Clinical Research DeLand, Deland, Florida, 32720, United States; Recruiting
Albert J. Razzetti, MD, Principal Investigator
Illinois
nTouch Research, Peoria, Illinois, 61602, United States; Recruiting
Ben Dolin, MD, Principal Investigator
Michigan
Synergy Medical Education Alliance, Saginaw, Michigan, 48602, United States; Recruiting
Christine Rohr, DO, Principal Investigator
Mississippi
CRC of Jakson, Jackson, Mississippi, 39202, United States; Recruiting
Donald Brannan, MD, Principal Investigator
Missouri
Mercy Medical Group, St. Louis, Missouri, 63141, United States; Recruiting
Timothy Smith, MD, Principal Investigator
New York
Tobey Village Office Park, Pittsford, New York, 14534, United States; Recruiting
Chung H. Kim, MD, Principal Investigator
North Carolina
Piedmont Medical Research Assoc., Inc., Winston Salem, North Carolina, 27103, United States; Recruiting
Robert J. Holmes, MD, Principal Investigator
LeBauer Research Associates, PA, Greensboro, North Carolina, 27403, United States; Recruiting
Robert D. Kaplan, MD, Principal Investigator
Medoff Medical / Vital Research, Greensboro, North Carolina, 27408, United States; Recruiting
Jeffery R. Medoff, MD, Principal Investigator
Hanover Medical Specialists, PA, Wilmington, North Carolina, 28401, United States; Recruiting
James Mertesdorf, MD, Principal Investigator
Ohio
Consultants for Clinical Research, Cincinnati, Ohio, 45219, United States; Recruiting
Michael Safdi, MD, Principal Investigator
Radient Research, Columbus, Ohio, 43212, United States; Recruiting
Douglas Schumaker, MD, Principal Investigator
Pennsylvania
Grandview Medical Research, Inc, Sellersville, Pennsylvania, 18960, United States; Recruiting
James Conrad, MD, Principal Investigator
South Carolina
Anderson Gastroenterology, Anderson, South Carolina, 29621, United States; Recruiting
Charles W. Scowcroft, MD, Principal Investigator
Tennessee
Jackson Clinic, Jackson, Tennessee, 38301, United States; Recruiting
James Egan, MD, Principal Investigator
ClinSearch, Chattanooga, Tennessee, 37404, United States; Recruiting
Richard A. Krause, MD, Principal Investigator
TriCities Medical Research, Bristol, Tennessee, 37620, United States; Recruiting
David J. Morin, MD, Principal Investigator
Memphis Gastroenterology, Memphis, Tennessee, 38120, United States; Recruiting
Lawrence Wruble, MD, Principal Investigator
Texas
Radiant Research Dallas-North, Dallas, Texas, 75231, United States; Recruiting
Michele D. Reynolds, MD, Principal Investigator
Washington
Tacoma Digestive Disease Research Center, Tacoma, Washington, 98405, United States; Recruiting
Brian L. Bleau, MD, Principal Investigator
More Information
Record last reviewed: February 2005
Last Updated: February 3, 2005
Record first received: January 12, 2005
ClinicalTrials.gov Identifier: NCT00101725
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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