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

Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01225237

Enrollment

296

Registered

2010-10-20

Start date

2010-10-31

Completion date

2011-08-31

Last updated

2014-10-15

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 disease, YM060

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.

Interventions

DRUGRamosetron

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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 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

Design outcomes

Primary

Measure	Time frame
Responder rate of stool form normalization	For 4 weeks

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026