Specified Drug Use-results Survey of Betanis Tablets | NCT01898624

Studies
Specified Drug Use-results Survey of Betanis Tablets

NCT01898624

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Feb 5, 2018Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Overactive Bladder

Interventions

mirabegron

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2012Actual

Primary Completion Date

Jan 10, 2018Actual

Completion Date

Jan 10, 2018Actual

First Submitted Date

Jul 10, 2013

First Submission Date that Met QC Criteria

Jul 10, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2018

Last Update Posted Date

Feb 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Betanis group		mirabegron treated group	Drug: mirabegron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mirabegron	Drug	oral	Betanis group	Betanis YM178

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

OAB patients with coexisting glaucoma treated with mirabegron

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive
D005901	Glaucoma

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520025	mirabegron

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chugoku			Japan