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

Astellas Pharma Inc98 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

RamosetronDRUG

oral

PlaceboDRUG

oral

Eligibility

Sex: MALEMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Unnamed facility

Kyusyu, Japan

Outcomes

Primary Outcomes

IBS severity index (Japanese version)

Time frame: 12 weeks

Secondary Outcomes

Patient reported global assessment of relief of IBS symptoms

Time frame: 12 weeks

Patient reported assessment of relief of abdominal discomfort and/or pain

Time frame: 12 weeks

Patient reported assessment of improvement of abdominal bowel habits

Time frame: 12 weeks

Data from ClinicalTrials.gov

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