Phase 2 N=148 Randomized Triple-blind Treatment

Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Irritable Bowel Syndrome With Diarrhea

Bottom Line

View on ClinicalTrials.gov: NCT01177410 ↗

Enrolled (actual)

148

Serious AEs

0.7%

Results posted

Sep 2012

Primary outcome: Primary: The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months. — 18; 27; 28; 9 participants — p=0.0327

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); Mesalamine Granules 750 mg (Drug); Mesalamine Granules 1500 mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch Health Americas, Inc.
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.	18; 27; 28; 9; 5; 8	0.0327 sig
SECONDARY 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	24; 15; 14	0.0432 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01177410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.