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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ramosetron group

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

oral

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Interventions

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Ramosetron

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Other Intervention Names

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Irribow YM060

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No