Diarrhea Predominant Irritable Bowel Syndrome in Females

This study has been completed.

Sponsor:

Information provided by:

Salix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00461526

First received: November 9, 2006

Last updated: November 19, 2010

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	November 9, 2006
Last Updated Date	November 19, 2010
Start Date ^ICMJE	October 2006
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	To assess the safety of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ] [ Designated as safety issue: Yes ] To assess the efficacy of TRN-002 when administered twice daily for 12 consecutive weeks. [ Time Frame: March 2008 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: April 13, 2007)	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.
Change History	Complete list of historical versions of study NCT00461526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Diarrhea Predominant Irritable Bowel Syndrome in Females
Official Title ^ICMJE	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
Brief Summary	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	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
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Irritable Bowel Syndrome
Intervention ^ICMJE	Drug: crofelemer 125 mg crofelemer vs. placebo
Study Arm (s)	Experimental: 125 mg crofelemer Intervention: Drug: crofelemer Placebo Comparator: placebo Intervention: Drug: crofelemer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	240
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00461526
Other Study ID Numbers ^ICMJE	TRN-002-202
Has Data Monitoring Committee	Yes
Responsible Party	Michelle Widmann, Associate Director, Clinical Operations, Salix Pharmaceuticals
Study Sponsor ^ICMJE	Salix Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Salix Pharmaceuticals
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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