Drug Use-Results Survey of Betanis Tablets in Japan

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919047
• Other study ID #: BE0001
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: October 2, 2015
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10711
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Betanis
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events and adverse drug reactions		For 12 weeks	Yes
Secondary	Changes in OABSS (overactive bladder symptom score)		baseline and at 12 weeks (or last observation period)	No
Secondary	Items of particular interest		baseline and at 12 weeks (or last observation period)	Yes