A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: placebo; Drug: YM060

• Registration Number: NCT01274000
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 409

Inclusion Criteria

• Patients meeting the Rome III Diagnostic Criteria
• Loose (mushy) or watery stools within the last 3 months
• Abdominal discomfort and/or pain during their non-menstrual period

Exclusion Criteria

• Patients with a history of surgical resection of the stomach, small intestine or large intestine
• Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
• Patients with a history or current diagnosis of colitis ischemic
• Patients with a current diagnosis of enteritis infectious
• Patients with a current diagnosis of hyperthyroidism or hypothyroidism
• Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
• Patients with a history or current diagnosis of malignant tumor
• Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	-
YM060 middle-dose group	YM060	-
YM060 high-dose group	YM060	-
YM060 low-dose group	YM060	-

Primary Outcome Measures

Name	Time	Method
Responder rate of patients reported global assessment of relief of IBS symptoms	for 4 weeks

Secondary Outcome Measures

Name	Time	Method
Responder rate of patients reported assessment of improvement of abnormal bowel habits	for 4 weeks
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain	for 4 weeks
Change in weekly average scores of stool form (appearance)	Baseline and for 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in lab-tests	for 4 weeks