A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
|ClinicalTrials.gov Identifier: NCT00101725|
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : November 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease||Drug: crofelemer||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Study Start Date :||December 2004|
|Primary Completion Date :||November 2005|
|Study Completion Date :||November 2005|
|Experimental: 125 mg crofelemer||Drug: crofelemer|
|Experimental: 250 mg crofelemer||Drug: crofelemer|
|Experimental: 500 mg crofelemer||Drug: crofelemer|
|Placebo Comparator: placebo||Drug: crofelemer|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101725
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