A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

NCT ID: NCT00749632

Last Updated: 2009-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Detailed Description

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Conditions

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Urinary Incontinence, Urge

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

oxybutynin

Intervention Type DRUG

low dose oxybutynin administered daily

2

Group Type ACTIVE_COMPARATOR

oxybutynin

Intervention Type DRUG

middle dose oxybutynin administered daily

3

Group Type ACTIVE_COMPARATOR

oxybutynin

Intervention Type DRUG

high dose oxybutynin administered daily

Interventions

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oxybutynin

low dose oxybutynin administered daily

Intervention Type DRUG

oxybutynin

middle dose oxybutynin administered daily

Intervention Type DRUG

oxybutynin

high dose oxybutynin administered daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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FemmePharma Global Healthcare, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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FemmePharma Global Healthcare, Inc.

Principal Investigators

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Peter K. Mays, Ph.D.

Role: STUDY_DIRECTOR

FemmePharma Global Healthcare, Inc.

Locations

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SNBL Clinical Pharmacology Center

Baltimore, Maryland, United States

Site Status

Advanced Biomedical Research

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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FP1097-002

Identifier Type: -

Identifier Source: org_study_id

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