Diarrhea Predominant Irritable Bowel Syndrome in Females

Study Overview
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Brief Summary
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Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS) The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. 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 will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks. The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis. Participants must meet all of the following criteria: Females at least 18 years of age 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 in the past 5 years. Willingness to take an approved method of birth control (if required) Participants CANNOT meet any of the following criteria: Serious medical or surgical conditions Colon Cancer, Crohns Disease or Ulcerative Colitis Pregnant or breast feeding

Detailed Description
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Clinical Trial with TRN-002 in Women with Irritable Bowel Syndrome (IBS) The purpose of this study is to investigate the safety and effectiveness of a new investigational drug in women for the treatment of diarrhea-predominant irritable bowel syndrome. 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 will be not able to remain on certain standard IBS medications (anti-diarrheals) while participating in the study. The total duration of the study is 18 weeks. The study requires five study visits that include physical exams, ECG, blood draws, laboratory studies, and a colon procedure (such as a colonoscopy or flexible sigmoidoscopy if an appropriate procedure has not been performed in the last 5 years.) Participants will be asked to make entries into a touch-tone telephone diary on a daily basis. Participants must meet all of the following criteria: Females at least 18 years of age 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 in the past 5 years. Willingness to take an approved method of birth control (if required) Participants CANNOT meet any of the following criteria: Serious medical or surgical conditions Colon Cancer, Crohns Disease or Ulcerative Colitis Pregnant or breast feeding

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) in Females

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: crofelemer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females at least 18 years of age 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 in the past 5 years. Willingness to take an approved method of birth control (if required) Exclusion Criteria: Serious medical or surgical conditions Colon Cancer, Crohns Disease or Ulcerative Colitis Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 125 mg crofelemer<br> | Drug: crofelemer<br>* 125 mg crofelemer vs. placebo<br>|
| Placebo Comparator: placebo<br> | Drug: crofelemer<br>* 125 mg crofelemer vs. placebo<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. |  | March 2008 | 
| To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. |  | March 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, d-IBS, Irritable Bowel Syndrome