A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

Phase 3

Completed

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

• Registration Number: NCT01736423
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 151

Inclusion Criteria

Female patients who meet the following 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

Patients who meet any of the following 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Female Patients with D-IBS	YM060	-

Primary Outcome Measures

Name	Time	Method
Monthly responder rate of stool form normalization	up to 52 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits	up to 52 weeks
Change in weekly average of scores of stool form	up to 52 weeks
Rate of days without urgency	up to 52 weeks
Rate of days without feeling of incomplete bowel movement	up to 52 weeks
Monthly responder rate of global assessment of relief of overall IBS symptoms	up to 52 weeks
Change in weekly average of stool frequency	up to 52 weeks
Monthly responder rate of global assessment of relief of abdominal pain/discomfort	up to 52 weeks
Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales	4, 8, 12, 28 and 52 weeks
Change in weekly average of scores of severity of abdominal pain/discomfort	up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Safety assessed through AEs and clinical laboratory values	up to 52 weeks