A Study Measuring and Tracking Changes in Overactive Blad... | NCT01317810

Studies
A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication

NCT01317810

Sponsor

Astellas Pharma Inc

Status

Withdrawn

Last Update Posted

Sep 2, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Overactive Bladder (OAB)

Interventions

Not provided

Countries

Not provided

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

Aug 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Corporate decision not to initiate the trial

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

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

Aug 31, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

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

The purpose of this study is to track changes in overactive bladder (OAB) medical regimen and/or OAB medication dosage requirements.

Detailed Description

Subjects will complete a study specific survey questionnaire at Screening and the Month 1 through Month 6 visits. Subjects will be followed for 6 months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with Overactive Bladder (OAB)		Combination of new OAB subjects and existing subjects on OAB medication

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in overactive bladder (OAB) medication/ treatment regimen		6 months
Reason for change in OAB medication/treatment regimen		6 months

Secondary Outcomes

Measure	Description	Time Frame
Persistence of use of any OAB medication as reported by the Physician		6 months
Change in OAB medication including discontinuation of OAB medication as reported by the Physician		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has overactive bladder as determined by their prescribing physician
Subject is currently receiving pharmacotherapy for overactive bladder
Subject is willing to comply with required protocol/study requirements

Exclusion Criteria:

Subject has a history of a clinically significant illness or medical condition prior to screening that would preclude participation in the study
Male subjects with Lower Urinary Tract Symptoms (LUTS) or Bladder Outlet Obstruction (BOO)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with overactive bladder (OAB)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Global Development, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

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