Drug Use-Results Survey of Betanis Tablets in Japan

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Betanis

• Registration Number: NCT01919047
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10711

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Betanis group	Betanis	Patients receiving Betanis for Overactive Bladder

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events and adverse drug reactions	For 12 weeks

Secondary Outcome Measures

Name	Time	Method
Items of particular interest	baseline and at 12 weeks (or last observation period)
Changes in OABSS (overactive bladder symptom score)	baseline and at 12 weeks (or last observation period)