Clinical trial NCT00909181: Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urge Urinary Incontinence
Urinary Frequency
Lead sponsor: Antares Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: New Britain
country: United States
state: Connecticut
city: N. Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Sandy Springs
country: United States
state: Georgia
city: Stockbridge
country: United States
state: Georgia
city: Evanston
country: United States
state: Illinois
city: West Des Moines
country: United States
state: Iowa
city: Shreveport
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Watertown
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Brooklyn
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Wadsworth
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Corvallis
country: United States
state: Oregon
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Landsdale
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Fayetteville
country: United States
state: Tennessee
city: Provo
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
References: