A Study of Oxybutynin for the Treatment of Urge Urinary I... | NCT00749632

Studies
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

NCT00749632

Sponsor

FemmePharma Global Healthcare, Inc.

Status

Completed

Last Update Posted

Oct 15, 2009Estimated

Enrollment

45Actual

Phase

Phase 2

Conditions

Urinary Incontinence, Urge

Interventions

oxybutynin
oxybutynin
oxybutynin

Countries

United States

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

Oct 2009

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

Jul 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Sep 5, 2008

First Submission Date that Met QC Criteria

Sep 8, 2008

First Posted Date

Sep 9, 2008Estimated

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

Oct 13, 2009

Certification/Extension First Submitted that Passed QC Review

Oct 13, 2009

Certification/Extension First Posted Date

Oct 15, 2009Estimated

Last Update Submitted Date

Oct 13, 2009

Last Update Posted Date

Oct 15, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

FemmePharma Global Healthcare, Inc.INDUSTRY

Collaborators

Not provided

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 determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Active Comparator	Drug: oxybutynin
2	Active Comparator	Drug: oxybutynin
3	Active Comparator	Drug: oxybutynin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxybutynin	Drug	low dose oxybutynin administered daily	1
oxybutynin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of micturations and incontinence episodes.		Two weeks pretreatment and three weeks on treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females 18 to 75 years of age
Has reported symptoms of urge urinary incontinence/overactive bladder

Exclusion Criteria:

Is pregnant or lactating
Has had lower urinary tract surgery within 6 months prior to Screening
Has a history of urinary retention

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter K. Mays, Ph.D.	FemmePharma Global Healthcare, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SNBL Clinical Pharmacology Center		Baltimore	Maryland	21201	United States
Advanced Biomedical Research

Condition Browse Module

MeSH Terms

ID	Term
D053202	Urinary Incontinence, Urge

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C005419	oxybutynin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided