Back to resultsA Study of Oxybutynin for the Treatment of Urge Urinary Incontinence (FP1097-002)
Primary Purpose
Urinary Incontinence, Urge
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxybutynin
oxybutynin
oxybutynin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring urinary incontinence, urge, urinary urge incontinence, urge incontinence, over active bladder
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
Sites / Locations
- SNBL Clinical Pharmacology Center
- Advanced Biomedical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Number of micturations and incontinence episodes.
Secondary Outcome Measures
Full Information
NCT ID
NCT00749632
First Posted
September 5, 2008
Last Updated
October 13, 2009
Sponsor
FemmePharma Global Healthcare, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00749632
Brief Title
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
Acronym
FP1097-002
Official Title
An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
FemmePharma Global Healthcare, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
urinary incontinence, urge, urinary urge incontinence, urge incontinence, over active bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
oxybutynin
Intervention Description
low dose oxybutynin administered daily
Intervention Type
Drug
Intervention Name(s)
oxybutynin
Intervention Description
middle dose oxybutynin administered daily
Intervention Type
Drug
Intervention Name(s)
oxybutynin
Intervention Description
high dose oxybutynin administered daily
Primary Outcome Measure Information:
Title
Number of micturations and incontinence episodes.
Time Frame
Two weeks pretreatment and three weeks on treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter K. Mays, Ph.D.
Organizational Affiliation
FemmePharma Global Healthcare, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
SNBL Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Advanced Biomedical Research
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence
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