Status:
COMPLETED
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
Lead Sponsor:
Antares Pharma Inc.
Conditions:
Urge Urinary Incontinence
Urinary Frequency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the exten...
Eligibility Criteria
Inclusion
- Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months
- Have a history of at least 1 - 2 urge episodes and 8 or more voids per day
Exclusion
- Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications
- PVR volume \> 200 mL or relative PVR \> 50% of pre-void volume as determined by bladder ultrasound
- History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT00909181
Start Date
March 1 2009
End Date
November 1 2010
Last Update
July 2 2014
Active Locations (55)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35233
2
Little Rock, Arkansas, United States, 72211
3
Laguna Hills, California, United States, 92653
4
Los Angeles, California, United States, 90048