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NCT00749632 Clinical Trial

A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

Urinary Incontinence, Urge Clinical Trial

— FP1097-002  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00749632
Other study ID # FP1097-002
Secondary ID
Status Completed
Phase Phase 2
First received September 5, 2008
Last updated October 13, 2009
Start date July 2007
Est. completion date October 2008

Study information
Verified date October 2009
Source FemmePharma Global Healthcare, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States SNBL Clinical Pharmacology Center Baltimore Maryland
United States Advanced Biomedical Research Hackensack New Jersey

Sponsors (1)
Lead Sponsor Collaborator
FemmePharma Global Healthcare, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of micturations and incontinence episodes. Two weeks pretreatment and three weeks on treatment No
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