A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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)

Conditions
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Irritable Bowel Syndrome, Colonic Diseases, Diarrhea, Gastrointestinal Disease

Intervention / Treatment
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* Drug: crofelemer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 125 mg crofelemer<br> | Drug: crofelemer<br> <br> |
| Experimental: 250 mg crofelemer<br> | Drug: crofelemer<br> <br> |
| Experimental: 500 mg crofelemer<br> | Drug: crofelemer<br> <br> |
| Placebo Comparator: placebo<br> | Drug: crofelemer<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea, IBS, Irritable Bowel Syndrome, Abdominal pain