A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female 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

PHASE2

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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A study to verify the superiority of YM060 (ramosetron) to placebo for female 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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placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

YM060 low-dose group

Group Type EXPERIMENTAL

YM060

Intervention Type DRUG

oral

YM060 middle-dose group

Group Type EXPERIMENTAL

YM060

Intervention Type DRUG

oral

YM060 high-dose group

Group Type EXPERIMENTAL

YM060

Intervention Type DRUG

oral

Interventions

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YM060

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Other Intervention Names

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ramosetron, Irribow

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
* Abdominal discomfort and/or pain during their non-menstrual period

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

FEMALE

Accepts Healthy Volunteers

No