A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

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

PHASE3

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).

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Detailed Description

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Conditions

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Diarrhea-predominant 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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YM060 group

Group Type EXPERIMENTAL

YM060

Intervention Type DRUG

oral

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

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

1. Patients satisfying the Rome III Diagnostic Criteria
2. Patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools
3. Patients who have abdominal pain or discomfort
4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion Criteria

1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
2. Patients with a history or current evidence of inflammatory bowel disease
3. Patients with a history or current evidence of colitis ischemic
4. Patients with concurrent infectious enteritis
5. Patients with concurrent hyperthyroidism or hypothyroidism
6. Patients with concurrent active peptic ulcer
7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No