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

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.

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