A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Ramosetron

• Registration Number: NCT00918411
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 98

Inclusion Criteria

• Patients meeting the Rome III Diagnostic Criteria
• Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria

• Patients having hyperthyroidism or hypothyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	oral
Ramosetron group	Ramosetron	oral

Primary Outcome Measures

Name	Time	Method
IBS severity index (Japanese version)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Patient reported assessment of improvement of abdominal bowel habits	12 weeks
Patient reported global assessment of relief of IBS symptoms	12 weeks
Patient reported assessment of relief of abdominal discomfort and/or pain	12 weeks