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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
577
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyushu, Japan
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
Time frame: Up to 12 weeks
Monthly responder rate of stool form normalization at final point
Time frame: Up to 12 weeks
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Time frame: Up to 12 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Time frame: Up to 12 weeks
Change in weekly average scores of severity of abdominal pain/discomfort
Time frame: Up to 12 weeks
Change in weekly average scores of stool form
Time frame: Up to 12 weeks
Safety assessment of YM060
Time frame: Up to 12 weeks
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