A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

Phase 4

Completed

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

• Registration Number: NCT01225237
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 296

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ramosetron group	Ramosetron	-
Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Responder rate of stool form normalization	For 4 weeks

Secondary Outcome Measures

Name	Time	Method
Responder rate of patients reported global assessment of relief of IBS symptoms	For 4 weeks
Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain	For 4 weeks
Responder rate of patients reported assessment of improvement of abnormal bowel habits	For 4 weeks
Safety assessed by the incidence of adverse events and abnormal values in labo-tests	For 4 weeks