Special Drug Use Surveillance of Irribow in Female Patients

October 18, 2024 updated by: Astellas Pharma Inc

Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

793

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
      • Akita, Japan
      • Chiba, Japan
      • Fukui, Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Gifu, Japan
      • Gunma, Japan
      • Hiroshima, Japan
      • Hyogo, Japan
      • Ibaraki, Japan
      • Iwate, Japan
      • Kagoshima, Japan
      • Kanagawa, Japan
      • Kumamoto, Japan
      • Kyoto, Japan
      • Mie, Japan
      • Miyagi, Japan
      • Miyazaki, Japan
      • Nagano, Japan
      • Niigata, Japan
      • Oita, Japan
      • Okayama, Japan
      • Okinawa, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Shiga, Japan
      • Shizuoka, Japan
      • Tochigi, Japan
      • Tokyo, Japan
      • Tottori, Japan
      • Toyama, Japan
      • Yamagata, Japan
      • Yamaguchi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients with diarrhea-predominant irritable bowel syndrome

Description

Inclusion Criteria:

  • Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ramosetron group
Female patients with diarrhea-predominant irritable bowel syndrome
Drug: Ramosetron
Oral
Other Names:
  • YM060
  • Irribow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidences of Adverse Drug Reactions
Time Frame: Up to Week 52
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in frequency of bowel movements
Time Frame: Baseline to Week 52
Frequency of bowel movements is recorded daily
Baseline to Week 52
Change from baseline in form of stool
Time Frame: Baseline to Week 52
Classified based on Bristol Stool Form Scale
Baseline to Week 52
Change from baseline in sensation of incomplete bowel evacuation
Time Frame: Baseline to Week 52
Assessment based on numerical rating scale
Baseline to Week 52
Change from baseline in defecation urgency
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from baseline in abdominal pain or discomfort
Time Frame: Baseline to Week 52
Abdominal pain or discomfort assessed based on numerical rating scale
Baseline to Week 52
Change from baseline in melena
Time Frame: Baseline to Week 52
Baseline to Week 52
Overall improvement
Time Frame: Up to Week 52
Classified into the three scales (improved, no change or aggravated) or concluded as indeterminable.
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Medical Director, Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimated)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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