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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
151
oral
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
Time frame: up to 52 weeks
Monthly responder rate of stool form normalization
Time frame: up to 52 weeks
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
Time frame: up to 52 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits
Time frame: up to 52 weeks
Change in weekly average of scores of severity of abdominal pain/discomfort
Time frame: up to 52 weeks
Change in weekly average of scores of stool form
Time frame: up to 52 weeks
Change in weekly average of stool frequency
Time frame: up to 52 weeks
Rate of days without urgency
Time frame: up to 52 weeks
Rate of days without feeling of incomplete bowel movement
Time frame: 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
Time frame: 4, 8, 12, 28 and 52 weeks
Safety assessed through AEs and clinical laboratory values
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Time frame: up to 52 weeks