Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).

Official Title
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A Prospective Double-Blind Placebo-Controlled Trial of Mosapride in Patients With Constipation-Predominant Irritable Bowel Syndrome

Conditions
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Constipation-Predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Mosapride Citrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rome III Criteria for IBS: Patients must have recurrent abdominal pain or discomfort at least 3 days per month during the previous 3 months that is associated with 2 or more of the following: Relieved by defecation Onset associated with a change in stool frequency Onset associated with a change in stool form or appearance In addition, patients have to experience at least two of the following symptoms for at least 25% of the time [11]: Altered stool frequency (< 3 bowel movements per week) Altered stool form (lumpy/hard i.e. Bristol type I-III [see appendix 1]) Altered stool passage (straining, urgency, or a feeling of incomplete evacuation) Passage of mucus, bloating, or a feeling of abdominal distension Exclusion Criteria: Previous allergy to mosapride Nocturnal Symptoms (pain in the middle of the night, or other nocturnal symptoms which suggest an organic disease) Age < 18 years History of bloody stools or melena Diarrhea (>3 bowel movements per day) Constitutional symptoms (fever, weight loss) Severe constipation (< 1 bm/week) Pregnancy or lactation Patients with history of cardiac arrhythmias QT prolongation on baseline ECG Chronic laxative use and dependence Patients with previous history of congenital heart disease Patients with previous history of hypokalemia or hyperkalemia Patients taking the following classes of drugs: HIV antivirals, macrolides, anti-arrhythmics, and azole drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Mosapride | Drug: Mosapride Citrate<br>* One 5 mg tablet taken orally three times per day (15 min before meals) for 8 weeks.<br>* Other names: Mosar;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* One tablet (identical in shape and form to the actual drug) taken orally three times per day (15 min before meals) for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome. |  | Within the first 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mosapride, Irritable Bowel Syndrome, Constipation