This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.
This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
559
oral
oral
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyusyu, Japan
Global assessment of relief of IBS symptoms Responder
Time frame: Weekly for 12 weeks
SBM (Spontaneous Bowel Movement) Responder
Time frame: Weekly for 12 weeks
CSBM (Complete SBM) Responder
Time frame: Weekly for 12 weeks
Abnormal bowel habits improvement Responder
Time frame: Weekly for 12 weeks
Abdominal pain/discomfort relief Responder
Time frame: Weekly for 12 weeks
Changes in weekly average of SBM frequency
Time frame: Weekly for 12 weeks
Changes in weekly average of CSBM frequency
Time frame: Weekly for 12 weeks
Changes in weekly average of stool form scores
Time frame: Weekly for 12 weeks
Changes in weekly average of abdominal pain/discomfort severity
Time frame: Weekly for 12 weeks
Changes in weekly average of straining severity
Time frame: Weekly for 12 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
Time frame: Weekly for 12 weeks
Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs
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Time frame: for 12 weeks