Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea

Study Overview
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Brief Summary
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The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.

Official Title
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Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study

Conditions
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Irritable Bowel Syndrome Without Diarrhea

Intervention / Treatment
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* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac)
* Drug: Probiotics (Medirac) placebo/mosapride placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS Signed informed consent Exclusion Criteria: IBS-D evidence of cathartic colon or history laxative abuse

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics(Medirac) 10/mosapride 10mg<br> | Drug: Probiotics (Medirac)<br>* 10/mosapride 10mg three times a day, P.O. 4week<br>|
| Experimental: Probiotics(Medirac) 15/mosapride 10mg<br> | Drug: Probiotics (Medirac)<br>* 15/mosapride 10mg three times a day, P.O. 4week<br>|
| Experimental: Probiotics(Medirac) 15/mosapride 15mg<br> | Drug: Probiotics (Medirac)<br>* 15/mosapride 15mg three times a day, P.O. 4week<br>|
| Experimental: Probiotics(Medirac) 30/mosapride 15mg<br> | Drug: Probiotics (Medirac)<br>* 30/mosapride 15mg three times a day, P.O. 4week<br>|
| Placebo Comparator: Probiotics(Medirac) placebo/mosapride placebo<br> | Drug: Probiotics (Medirac) placebo/mosapride placebo<br>* three times a day, P.O. 4week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms |  | baseline and 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks) |  | baseline and 4 weeks, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irritable bowel syndrome without predominant diarrhea, Probiotics(Medirac) 10/mosapride 10mg, Probiotics(Medirac) 15/mosapride 10mg, Probiotics(Medirac) 15/mosapride 15mg, Probiotics(Medirac) 30/mosapride 15mg, Probiotics(Medirac) placebo/mosapride placebo