The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).
\<Period I (double-blind period)\> A multicenter, collaborative, double-blind, parallel comparative study is conducted using IBS-C patients as subjects to verify efficacy of ASP0456 and examine the safety. After the 2-week bowel habit observation period, subjects satisfying the primary enrollment criteria are randomly allocated to either ASP0456 group or placebo group, and orally administered the drug or placebo once daily before breakfast for 12 weeks. \<Period II (non-blind period)\> A multicenter, collaborative, non-blind, non-controlled study is conducted to examine safety and efficacy of ASP0456 in long-term administration in IBS-C patients. After Period I, subjects satisfying the transfer criteria are orally administered ASP0456 once daily before breakfast for 40 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
Oral administration once daily
Oral administration once daily
Responder rate of Global assessment of relief of IBS symptoms during 12 weeks.
The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.
Time frame: During 12 weeks
Responder rate of CSBM during 12 weeks
CSBM: Complete Spontaneous Bowel Movement. The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.
Time frame: During 12 weeks
Responder rate of SBM during 12 weeks
SBM: Spontaneous Bowel Movement
Time frame: During 12 weeks
Responder rate of Abnormal bowel habits improvement during 12 weeks
Time frame: During 12 weeks
Responder rate of Abdominal pain/discomfort relief during 12 weeks
Time frame: During 12 weeks
Weekly responder rate of Global assessment of relief of IBS symptoms
The weekly responder of the evaluation items shall be the subject satisfying the followings at the time of evaluation in each week.Score of Global assessment of relief of IBS symptoms (7 scores: 1-7) is 1 or 2
Time frame: Up to 52 weeks
Weekly responder rate of CSBM
Weekly responder of CSBM: The weekly mean value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period
Time frame: Up to 52 weeks
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Site JP00004
Aichi, Japan
Site JP00048
Aichi, Japan
Site JP00049
Aichi, Japan
Site JP00038
Chiba, Japan
Site JP00039
Chiba, Japan
Site JP00040
Chiba, Japan
Site JP00041
Chiba, Japan
Site JP00042
Chiba, Japan
Site JP00002
Fukuoka, Japan
Site JP00060
Fukuoka, Japan
...and 51 more locations
Weekly responder rate of SBM
Weekly responder of SBM: The weekly mean value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period
Time frame: Up to 52 weeks
Weekly responder rate of Abnormal bowel habits improvement
Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2
Time frame: Up to 52 weeks
Weekly responder rate of Abdominal pain/discomfort relief
Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.
Time frame: Up to 52 weeks
Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity.
Time frame: From baseline to every week until 52 weeks
Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52
Percentage of subjects with SBM within 24 hours after start of the initial administration
Time frame: Up to 24 hours
Percentage of subjects with CSBM within 24 hours after start of the initial administration
Time frame: Up to 24 hours
Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests
Time frame: Up to 52 weeks