Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
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
1 other identifier
interventional
148
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
September 27, 2012
CompletedNovember 21, 2019
November 1, 2019
1.1 years
July 30, 2010
August 21, 2012
November 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
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.
3 months
Secondary Outcomes (1)
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
3 months
Study Arms (3)
Placebo
PLACEBO COMPARATORMesalamine Granules 750 mg
EXPERIMENTALMesalamine Granules 1500 mg
EXPERIMENTALInterventions
750 mg mesalamine granules once daily for 12 weeks
1500 mg mesalamine granules once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Sherwood, Arkansas, 72120, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Sacramento, California, 95831, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Bristol, Connecticut, 06010, United States
Unknown Facility
Boynton Beach, Florida, 33426, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
Macon, Georgia, 31201, United States
Unknown Facility
Shreveport, Louisiana, 71103, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Wyoming, Michigan, 49519, United States
Unknown Facility
Mexico, Missouri, 65265, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
Plano, Texas, 75075, United States
Unknown Facility
Ogden, Utah, 84405, United States
Unknown Facility
Lynchburg, Virginia, 24502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President of Clinical Operations
- Organization
- Salix Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 9, 2010
Study Start
July 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 21, 2019
Results First Posted
September 27, 2012
Record last verified: 2019-11