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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00918411

Enrollment

Registered

2009-06-11

Start date

2009-06-30

Completion date

2009-12-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

diarrhea, IBS, Colonic diseases, YM060

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).

Interventions

DRUGRamosetron

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
IBS severity index (Japanese version)	12 weeks

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026