A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence (FP1097-002)

This study has been completed.

Sponsor:

Information provided by:

FemmePharma Global Healthcare, Inc.

ClinicalTrials.gov Identifier:

NCT00749632

First received: September 5, 2008

Last updated: October 13, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 5, 2008

Last Updated Date

October 13, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of micturations and incontinence episodes. [ Time Frame: Two weeks pretreatment and three weeks on treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00749632 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

Official Title ^ICMJE

An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Urinary Incontinence, Urge

Intervention ^ICMJE

Drug: oxybutynin
low dose oxybutynin administered daily
Drug: oxybutynin
middle dose oxybutynin administered daily
Drug: oxybutynin
high dose oxybutynin administered daily

Study Arm (s)

Active Comparator: 1
Intervention: Drug: oxybutynin
Active Comparator: 2
Intervention: Drug: oxybutynin
Active Comparator: 3
Intervention: Drug: oxybutynin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00749632

Other Study ID Numbers ^ICMJE

FP1097-002

Has Data Monitoring Committee

Responsible Party

Peter K. Mays, Ph.D. / V.P. Pharmaceutical Development, FemmePharma Global Healthcare, Inc.

Study Sponsor ^ICMJE

FemmePharma Global Healthcare, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Peter K. Mays, Ph.D.

FemmePharma Global Healthcare, Inc.

Information Provided By

FemmePharma Global Healthcare, Inc.

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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