Special Drug Use Surveillance of Irribow in Female Patients

NCT ID: NCT02612649

Last Updated: 2024-10-21

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

Total Enrollment

793 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2018-03-31

Brief Summary

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The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.

Detailed Description

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Conditions

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Diarrhea-predominant Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ramosetron group

Female patients with diarrhea-predominant irritable bowel syndrome

Ramosetron

Intervention Type DRUG

Oral

Interventions

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Ramosetron

Oral

Intervention Type DRUG

Other Intervention Names

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YM060 Irribow

Eligibility Criteria

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Inclusion Criteria

* Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Numakunai, Iwate, Japan

Site Status

Aichi, , Japan

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Akita, , Japan

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Chiba, , Japan

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Fukui, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Gifu, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Mie, , Japan

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Miyagi, , Japan

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Miyazaki, , Japan

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Nagano, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saitama, , Japan

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Shiga, , Japan

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Shizuoka, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Tottori, , Japan

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Toyama, , Japan

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Yamagata, , Japan

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Yamaguchi, , Japan

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Countries

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Japan

Other Identifiers

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IB0002

Identifier Type: -

Identifier Source: org_study_id

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