A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).

Official Title
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A Long Term Study of YM060 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients who meet the following 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 who meet any of the following 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Female Patients with D-IBS<br> | Drug: YM060<br>* oral<br>* Other names: Ramosetron;|

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 |  | up to 52 weeks | 
| Monthly responder rate of stool form normalization |  | up to 52 weeks | 
| Monthly responder rate of global assessment of relief of abdominal pain/discomfort |  | up to 52 weeks | 
| Monthly responder rate of global assessment of improvement of abnormal bowel habits |  | up to 52 weeks | 
| Change in weekly average of scores of severity of abdominal pain/discomfort |  | up to 52 weeks | 
| Change in weekly average of scores of stool form |  | up to 52 weeks | 
| Change in weekly average of stool frequency |  | up to 52 weeks | 
| Rate of days without urgency |  | up to 52 weeks | 
| Rate of days without feeling of incomplete bowel movement |  | up to 52 weeks | 
| Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales |  | 4, 8, 12, 28 and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed through AEs and clinical laboratory values |  | up to 52 weeks | 

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