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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
409
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyusyu, Japan
Responder rate of patients reported global assessment of relief of IBS symptoms
Time frame: for 4 weeks
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
Time frame: for 4 weeks
Responder rate of patients reported assessment of improvement of abnormal bowel habits
Time frame: for 4 weeks
Change in weekly average scores of stool form (appearance)
Time frame: Baseline and for 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in lab-tests
Time frame: for 4 weeks
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