A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

NCT01870895 Phase 3 COMPLETED

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

Details

Lead sponsor	Astellas Pharma Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	577
Start date	2013-02
Completion	2014-02

Conditions

• Diarrhea-predominant Irritable Bowel Syndrome

Interventions

• YM060
• Placebo

Primary outcomes

• Monthly responder rate of global assessment of relief of overall IBS symptoms at final point — Up to 12 weeks
• Monthly responder rate of stool form normalization at final point — Up to 12 weeks

Countries

Japan