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NCT00918411 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

Official title:
Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00918411
Other study ID # 060-CL-500
Secondary ID
Status Completed
Phase Phase 4
First received June 9, 2009
Last updated October 9, 2015
Start date June 2009
Est. completion date December 2009

Study information
Verified date October 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 64 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Drug:
• Ramosetron
oral
• Placebo
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary IBS severity index (Japanese version) 12 weeks No
Secondary Patient reported global assessment of relief of IBS symptoms 12 weeks No
Secondary Patient reported assessment of relief of abdominal discomfort and/or pain 12 weeks No
Secondary Patient reported assessment of improvement of abdominal bowel habits 12 weeks No
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