A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Study Overview
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Brief Summary
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A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Official Title
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Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome

Conditions
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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 meeting the Rome III Diagnostic Criteria Loose (mushy) or watery stools within the last 3 months Abdominal discomfort and/or pain during their non-menstrual period Exclusion Criteria: Patients with a history of surgical resection of the stomach, small intestine or large intestine Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative) Patients with a history or current diagnosis of colitis ischemic Patients with a current diagnosis of enteritis infectious Patients with a current diagnosis of hyperthyroidism or hypothyroidism Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study Patients with a history or current diagnosis of malignant tumor Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

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 |
| --- | --- |
| Placebo Comparator: placebo group<br> | Drug: placebo<br>* oral<br>|
| Experimental: YM060 low-dose group<br> | Drug: YM060<br>* oral<br>* Other names: ramosetron, Irribow;|
| Experimental: YM060 middle-dose group<br> | Drug: YM060<br>* oral<br>* Other names: ramosetron, Irribow;|
| Experimental: YM060 high-dose group<br> | Drug: YM060<br>* oral<br>* Other names: ramosetron, Irribow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate of patients reported global assessment of relief of IBS symptoms |  | for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain |  | for 4 weeks | 
| Responder rate of patients reported assessment of improvement of abnormal bowel habits |  | for 4 weeks | 
| Change in weekly average scores of stool form (appearance) |  | Baseline and for 4 weeks | 
| Safety assessed by the incidence of adverse events and abnormal values in lab-tests |  | for 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, YM060, diarrhea, Colonic disease, Ramosetron