Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Salix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01177410

First received: July 30, 2010

Last updated: August 28, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2010
Last Updated Date	August 28, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 28, 2012)	The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months. [ Time Frame: 3 months ] [ Designated as safety issue: No ] A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
Original Primary Outcome Measures ^ICMJE (submitted: August 6, 2010)	The number of months that subjects are monthly responders for IBS-related abdominal pain [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01177410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 28, 2012)	Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period [ Time Frame: 3 months ] [ Designated as safety issue: No ] A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
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	Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
Official Title ^ICMJE	A Phase II, Randomized, Placebo-controlled, Double-blind, Multicenter, 12 Week Study to Assess the Efficacy and Safety of Mesalamine Granules 750 mg and 1,500 mg Capsules Administered Once Daily in the Treatment of Irritable Bowel Syndrome With Diarrhea
Brief Summary	The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
Detailed Description	Not Provided
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) Primary Purpose: Treatment
Condition ^ICMJE	Irritable Bowel Syndrome With Diarrhea
Intervention ^ICMJE	Drug: Placebo placebo capsules once daily for 12 weeks Drug: Mesalamine Granules 750 mg 750 mg mesalamine granules once daily for 12 weeks Drug: Mesalamine Granules 1500 mg 1500 mg mesalamine granules once daily for 12 weeks
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo Experimental: Mesalamine Granules 750 mg Intervention: Drug: Mesalamine Granules 750 mg Experimental: Mesalamine Granules 1500 mg Intervention: Drug: Mesalamine Granules 1500 mg
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	148
Completion Date	August 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria Meet the following IBS symptom scores in all categories during the diary eligibility period: An average daily score of greater than or equal to 3 for abdominal pain An average daily score of greater than or equal to 3 for bloating An average daily score of 5 or greater for stool consistency using the Bristol Stool Scale Does not have adequate relief of IBS symptoms (weekly reported) over the past 7 days on the first day of screening and on the day of randomization Exclusion Criteria: Present with hard or lumpy stools (Type 1 or Type 2) on the Bristol Stool form Scale during the diary eligibility period history of inflammatory bowel disease has Type 1 or 2 diabetes pregnant or lactating history of HIV or hepatitis B or C
Gender	Both
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	NCT01177410
Other Study ID Numbers ^ICMJE	MGIB2051
Has Data Monitoring Committee	No
Responsible Party	Salix Pharmaceuticals
Study Sponsor ^ICMJE	Salix Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Salix Pharmaceuticals
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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