Reproducibility Study of OABSS and Its Response to Treatment | NCT02667470

Studies
Reproducibility Study of OABSS and Its Response to Treatment

NCT02667470

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jan 29, 2016Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Overactive Bladder

Interventions

Solifenacin

Countries

Thailand

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 2016

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

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jan 26, 2016

First Submission Date that Met QC Criteria

Jan 26, 2016

First Posted Date

Jan 29, 2016Estimated

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 26, 2016

Last Update Posted Date

Jan 29, 2016Estimated

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 objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Solifenacin	Experimental		Drug: Solifenacin

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in OABSS scores from prior to treatment and after treatment		Prior to treatment and after treatment (up to 12 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Correlation of change between OABSS scores and number of micturitions per day		Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of incontinence episodes per day		Prior to treatment and after treatment (up to 12 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At screening visit (Week -2):
- Symptoms of OAB ≥ 3 months
- Number of urgency episodes in last 3 days ≥ 3
Based on the 3-day micturition diary prior to Visit 1 (Week 0):
- Number of micturition per day ≥ 8
- Number of urgency episodes in 3 days ≥ 3

Exclusion Criteria:

At screening visit (Week -2):
- Stress is the predominant factor as determined by the investigator
- Indwelling catheters or practicing intermittent self-catheterization
- Symptomatic urinary tract infection, chronic inflammation
- Treatment for OAB was started, quitted or changed in 4 weeks
- Diabetic neuropathy
At Visit 1 (Week 0):
- Patient who did not complete the 3-day micturition diary according to the instruction

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

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site: 1		Bangkok	Bangkok	10330	Thailand

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

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