Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Irritable Bowel Syndrome With Diarrhea

Intervention / Treatment
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* Drug: Placebo
* Drug: Mesalamine Granules 750 mg
* Drug: Mesalamine Granules 1500 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo capsules once daily for 12 weeks<br>|
| Experimental: Mesalamine Granules 750 mg<br> | Drug: Mesalamine Granules 750 mg<br>* 750 mg mesalamine granules once daily for 12 weeks<br>|
| Experimental: Mesalamine Granules 1500 mg<br> | Drug: Mesalamine Granules 1500 mg<br>* 1500 mg mesalamine granules once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Diarrhea, IBS-D, Irritable Bowel Syndrome, Abdominal pain, Bloating