A Study to Evaluate Response of Overactive Bladder Sympto... | NCT01122563

Studies
A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

NCT01122563

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jan 13, 2011Estimated

Enrollment

55Actual

Phase

Not provided

Conditions

Overactive Bladder

Interventions

Solifenacin

Countries

Indonesia

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

Jan 2011

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

Sep 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 11, 2010

First Submission Date that Met QC Criteria

May 11, 2010

First Posted Date

May 13, 2010Estimated

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

Jan 11, 2011

Last Update Posted Date

Jan 13, 2011Estimated

Name	Class
Astellas Pharma Indonesia Inc.	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

This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

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

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

55Actual

Name	Type	Description	Arm Group Labels	Other Names
Solifenacin	Drug	oral		Vesicare

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OABSS		Weeks 0, 4 and 12

Secondary Outcomes

Measure	Description	Time Frame
International Prostate Symptom Score (IPSS)		Weeks 0, 4 and 12
Quality of Life (QOL) Score		Weeks 0, 4 and 12
Patient Perception of Bladder Condition (PPBC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptoms OAB for 3 months or longer
At least 3 urgency episode in last 3 days
Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- Number of micturition ≥8 times/day
- Number of urgency episodes in 3 days ≥3

Exclusion Criteria:

Significant stress incontinence or mixed stress/urge incontinence
Subject with indwelling catheters or practicing intermittent self-catheterization
Symptomatic urinary tract infection, chronic inflammation
Diabetic neuropathy
Subjects who are prohibited from taking solifenacin as contraindications
Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
Participation in any clinical trial in 30 days except for Part-1 of RESORT

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

Symptomatic OAB patients having urgency episodes

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Indonesia	Study Chair

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

Intervention Browse Module

MeSH Terms

ID	Term
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Bandung			Indonesia