Clinical trial NCT00350636: A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: OAB, anticholineric, oxybutynin, urge urinary incontinence
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 789
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: A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria:

* Treatable conditions that may cause urinary incontinence
* Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Primary outcomes:
measure: Baseline Average Number of Daily Incontinence Episodes
timeFrame: Baseline
measure: Change From Baseline in Average Daily Number of Incontinence Episodes
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Baseline Average Daily Urinary Frequency
timeFrame: Baseline
measure: Change From Baseline in Average Daily Urinary Frequency
timeFrame: Baseline to 12 weeks
measure: Baseline Average Urine Void Volume
timeFrame: Baseline
measure: Change From Baseline in Average Urine Void Volume
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Homewood
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Laguna Woods
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Belville
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Melrose Park
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Watertown
country: United States
state: Massachusetts
city: Saginaw
country: United States
state: Michigan
city: St. Joseph
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Edmond
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Newton
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Watson Pharmaceuticals
name: Kim Caramelli, MS
role: STUDY_DIRECTOR
References:
citation: Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.