Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Completed · Phase 3 · Has a placebo group

Conditions studied: Urge Urinary Incontinence, Urinary Frequency

In brief

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 extended safety and skin-irritation profile of topically administered oxybutynin gel. The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.

Key facts

Study ID

NCT00909181

Run by

Antares Pharma Inc.

People needed

626

Starts

2009-03-01

Expected to finish

2010-11-01

Last updated by the study team

2014-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — New Britain, Connecticut, United States
• Study site — New Port Richey, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Sandy Springs, Georgia, United States
• Study site — Stockbridge, Georgia, United States
• Study site — Evanston, Illinois, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Annapolis, Maryland, United States
• Study site — Towson, Maryland, United States
• Study site — Watertown, Massachusetts, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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