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

October 13, 2009 updated by: FemmePharma Global Healthcare, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Advanced Biomedical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: oxybutynin
low dose oxybutynin administered daily
Drug: oxybutynin
middle dose oxybutynin administered daily
Drug: oxybutynin
high dose oxybutynin administered daily
Active Comparator: 1
Drug: oxybutynin
low dose oxybutynin administered daily
Drug: oxybutynin
middle dose oxybutynin administered daily
Drug: oxybutynin
high dose oxybutynin administered daily
Active Comparator: 3
Drug: oxybutynin
low dose oxybutynin administered daily
Drug: oxybutynin
middle dose oxybutynin administered daily
Drug: oxybutynin
high dose oxybutynin administered daily

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FemmePharma Global Healthcare, Inc.

Investigators

  • Study Director: Peter K. Mays, Ph.D., FemmePharma Global Healthcare, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

October 15, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP1097-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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