A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

Phase 3

Completed

• Conditions: Diarrhea-predominant Irritable Bowel Syndrome
• Interventions: Drug: YM060; Drug: Placebo

• Registration Number: NCT01870895
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 577

Inclusion Criteria

1. Patients satisfying the Rome III Diagnostic Criteria
2. Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
3. Patients who have abdominal pain or discomfort
4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion Criteria

1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
2. Patients with a history or current evidence of inflammatory bowel disease
3. Patients with a history or current evidence of colitis ischemic
4. Patients with concurrent infectious enteritis
5. Patients with concurrent hyperthyroidism or hypothyroidism
6. Patients with concurrent active peptic ulcer
7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YM060 group	YM060	-
Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Safety assessment of YM060	Up to 12 weeks
Monthly responder rate of global assessment of relief of abdominal pain/discomfort	Up to 12 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits	Up to 12 weeks
Change in weekly average scores of severity of abdominal pain/discomfort	Up to 12 weeks
Change in weekly average scores of stool form	Up to 12 weeks