Phase 2
Completed N=148
Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
Source: ClinicalTrials.gov NCT01177410 ↗Enrolled (actual)
148
Serious AEs
0.7%
Results posted
Sep 2012
Primary outcomePrimary: 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
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.
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 |
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
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. Informational only — not medical advice.