Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome With Diarrhea

Treatments: Drug: Placebo; Drug: Mesalamine Granules 1500 mg; Drug: Mesalamine Granules 750 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01177410

MGIB2051

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Mesalamine Granules 750 mg

Experimental group

Treatment:

Drug: Mesalamine Granules 750 mg

Mesalamine Granules 1500 mg

Experimental group

Treatment:

Drug: Mesalamine Granules 1500 mg