Drug Use-Results Survey of Betanis Tablets in Japan

October 2, 2015 updated by: Astellas Pharma Inc

Drug Use-Results Survey of Betanis Tablets 25 and 50 mg

This study is to determine the following information.

  1. The occurrence of adverse drug reactions in clinical settings.
  2. Factors potentially impacting safety, effectiveness, and other aspects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):

  1. The occurrence of adverse drug reactions in clinical settings.
  2. Factors potentially impacting safety, effectiveness, and other aspects.

Items of Particular Interest:

  • Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
  • Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
  • The occurrence of cardiovascular adverse events.
  • The occurrence of adverse events related to increased intraocular pressure.
  • The occurrence of urinary retention

Study Type

Observational

Enrollment (Actual)

10711

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
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Touhoku, 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

Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Description

Inclusion Criteria:

  • Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

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
Betanis group
Patients receiving Betanis for Overactive Bladder
Drug: Betanis
Oral
Other Names:
  • YM178
  • Mirabegron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events and adverse drug reactions
Time Frame: For 12 weeks
For 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in OABSS (overactive bladder symptom score)
Time Frame: baseline and at 12 weeks (or last observation period)
baseline and at 12 weeks (or last observation period)
Items of particular interest
Time Frame: baseline and at 12 weeks (or last observation period)
baseline and at 12 weeks (or last observation period)

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

April 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE0001

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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