A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
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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) |
- To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks.
- 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 |
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
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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 19, 2013