A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

Study Overview
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Brief Summary
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To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Official Title
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A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Conditions
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Diarrhea-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: YM060
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients satisfying the Rome III Diagnostic Criteria Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools Patients who have abdominal pain or discomfort Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema Exclusion Criteria: Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine Patients with a history or current evidence of inflammatory bowel disease Patients with a history or current evidence of colitis ischemic Patients with concurrent infectious enteritis Patients with concurrent hyperthyroidism or hypothyroidism Patients with concurrent active peptic ulcer Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

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: YM060 group<br> | Drug: YM060<br>* oral<br>* Other names: Irribow;|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly responder rate of global assessment of relief of overall IBS symptoms at final point |  | Up to 12 weeks | 
| Monthly responder rate of stool form normalization at final point |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly responder rate of global assessment of relief of abdominal pain/discomfort |  | Up to 12 weeks | 
| Monthly responder rate of global assessment of improvement of abnormal bowel habits |  | Up to 12 weeks | 
| Change in weekly average scores of severity of abdominal pain/discomfort |  | Up to 12 weeks | 
| Change in weekly average scores of stool form |  | Up to 12 weeks | 
| Safety assessment of YM060 |  | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM060, Ramosetron, Diarrhea-predominant Irritable Bowel Syndrome