A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
This study has been completed.
Sponsor:
Salix Pharmaceuticals
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00101725
First received: January 12, 2005
Last updated: November 19, 2010
Last verified: November 2010
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease |
Drug: crofelemer |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
Primary Outcome Measures:
- To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
Secondary Outcome Measures:
- To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks.
| Enrollment: | 245 |
| Study Start Date: | December 2004 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 125 mg crofelemer | Drug: crofelemer |
| Experimental: 250 mg crofelemer | Drug: crofelemer |
| Experimental: 500 mg crofelemer | Drug: crofelemer |
| Placebo Comparator: placebo | Drug: crofelemer |
Detailed Description:
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 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 (antidiarrheals) 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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101725
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Hide Study LocationsLocations
| United States, Alabama | |
| Clinical Research Associates | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Radiant Research Phoenix Southeast | |
| Chandler, Arizona, United States, 85225 | |
| United States, Arkansas | |
| Arkansas Gastroenterology | |
| North Little Rock, Arkansas, United States, 72117 | |
| United States, California | |
| AGMG Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Community Clinical Trials | |
| Orange, California, United States, 92868 | |
| AGMG Clinical Research | |
| Orange, California, United States, 92869 | |
| Institute of Healthcare Assessment, Inc. | |
| San Diego, California, United States, 92120 | |
| United States, District of Columbia | |
| Washington Gastroenterology | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Consultants for Clinical Research of South Florida | |
| Boynton Beach, Florida, United States, 33426 | |
| University Clinical Research DeLand | |
| DeLand, Florida, United States, 32720 | |
| United States, Illinois | |
| nTouch Research | |
| Peoria, Illinois, United States, 61602 | |
| United States, Michigan | |
| Synergy Medical Education Alliance | |
| Saginaw, Michigan, United States, 48602 | |
| United States, Mississippi | |
| CRC of Jakson | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Mercy Medical Group | |
| St. Louis,, Missouri, United States, 63141 | |
| United States, New York | |
| Tobey Village Office Park | |
| Pittsford, New York, United States, 14534 | |
| United States, North Carolina | |
| Medoff Medical / Vital Research | |
| Greensboro, North Carolina, United States, 27408 | |
| LeBauer Research Associates, PA | |
| Greensboro, North Carolina, United States, 27403 | |
| Hanover Medical Specialists, PA | |
| Wilmington, North Carolina, United States, 28401 | |
| Piedmont Medical Research Assoc., Inc. | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Consultants for Clinical Research | |
| Cincinnati, Ohio, United States, 45219 | |
| Radient Research | |
| Columbus, Ohio, United States, 43212 | |
| United States, Pennsylvania | |
| Grandview Medical Research, Inc | |
| Sellersville, Pennsylvania, United States, 18960 | |
| United States, South Carolina | |
| Anderson Gastroenterology | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Tennessee | |
| TriCities Medical Research | |
| Bristol, Tennessee, United States, 37620 | |
| ClinSearch | |
| Chattanooga, Tennessee, United States, 37404 | |
| Jackson Clinic | |
| Jackson, Tennessee, United States, 38301 | |
| Memphis Gastroenterology | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Radiant Research Dallas-North | |
| Dallas, Texas, United States, 75231 | |
| United States, Washington | |
| Tacoma Digestive Disease Research Center | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Salix Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Michelle Widmann, Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00101725 History of Changes |
| Other Study ID Numbers: | TRN 002 201 |
| Study First Received: | January 12, 2005 |
| Last Updated: | November 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
Diarrhea IBS Irritable Bowel Syndrome Abdominal pain |
Additional relevant MeSH terms:
|
Colonic Diseases Diarrhea Gastrointestinal Diseases Digestive System Diseases Irritable Bowel Syndrome |
Intestinal Diseases Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional |
ClinicalTrials.gov processed this record on May 23, 2013