Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial
Official title:
Phase III Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and Long-term Study in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
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.
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