Specified Drug Use-results Survey of Betanis Tablets

February 1, 2018 updated by: Astellas Pharma Inc

Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma

To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

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
      • Chubu, Japan
      • Chugoku, Japan
      • Kansai, Japan
      • Kanto, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Tohoku, 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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

OAB patients with coexisting glaucoma treated with mirabegron

Description

Inclusion Criteria:

  • diagnosed as OAB and treated with mirabegron
  • diagnosed as glaucoma (including normal tension glaucoma)
  • having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Betanis group
mirabegron treated group
Drug: mirabegron
oral
Other Names:
  • YM178
  • Betanis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in OABSS (Over Active Bladder Symptoms Score)
Time Frame: Baseline and 12 weeks of treatment
OABSS is judged by investigator
Baseline and 12 weeks of treatment

Collaborators and Investigators

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

Sponsor

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)

December 4, 2012

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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