Clinical trial NCT00196404: Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Official title: A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Keywords: overactive bladder
urge incontinence
urinary incontinence
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Detailed description: This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Eligibility criteria: Inclusion Criteria:

* Diagnosis of overactive bladder and incontinence for at least 6 months
* Using birth control or menopausal
* Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

* Pregnant or given birth in the last 6 months
* Three or more urinary tract infections a year
* Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
* History of bladder cancer, ulcerative colitis or severe constipation
* Any contraindication to vaginal delivery systems

Primary outcomes:
measure: Change in the total weekly number of incontinence episodes
timeFrame: Baseline to Treatment Week 12/Premature Discontinuation
Secondary outcomes:
measure: Average daily urinary frequency
timeFrame: Baseline to Treatment Week 12/Premature Discontinuation
measure: Proportion of patients with no incontinence episodes
timeFrame: Baseline to Treatment Week 12/Premature Discontinuation
measure: Average void volume
timeFrame: Baseline to Treatment Week 12/Premature Discontinuation
measure: Average severity of urgency
timeFrame: Baseline to Treatment Week 12/Premature Discontinuation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Research Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Research Site
state: Arizona
city: Little Rock
country: United States
facility: Duramed Investigational Site
state: Arkansas
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duremed Research Site
state: California
city: Aurora
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Duramed Research Site
state: Colorado
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Duramed Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Duramed Research Site
state: Florida
city: Decatur
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Duramed Research Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Boise
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Meridian
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Jackson
country: United States
facility: Duramed Investigational Site
state: Mississippi
city: Lebanon
country: United States
facility: Duramed Investigational Site
state: New Hampshire
city: Edison
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Livingston
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Williamsville
country: United States
facility: Duramed Investigational Site
state: New York
city: Portland
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Lancaster
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Duramed Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Research Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Waco
country: United States
facility: Duramed Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Seattle
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Research Site
state: Washington
city: Milwaukee
country: United States
facility: Duramed Investigational Site
state: Wisconsin
city: Vancouver
country: Canada
facility: Duramed Investigational Site
state: British Columbia
city: Toronto
country: Canada
facility: Duramed Investigational Site
state: Ontario
Study officials:
affiliation: Duramed Research
name: Medical Monitor
role: PRINCIPAL_INVESTIGATOR
References: