Clinical trial NCT00454896: A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Urinary Bladder, Overactive
Urgency
VESIcare®
Solifenacin succinate
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 739
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 purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.


Eligibility criteria: Inclusion Criteria:

* At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB
* Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
* Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion Criteria:

* Previous treatment with darifenacin
* Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for \<3 months
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the Investigator
* Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
* Clinically significant outflow obstruction (benign prostatic hyperplasia) as determined by the Investigator

Primary outcomes:
measure: Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome
timeFrame: Weeks 1, 4, 8 and 12
Secondary outcomes:
measure: Improvement of urgency
timeFrame: Weeks 1, 4, 8 and 12
measure: Improvement of frequency, incontinence and nocturia
timeFrame: Weeks 1, 4, 8 and 12
measure: Number of patients satisfied with treatment
timeFrame: Weeks 1, 4, 8 and 12
measure: Assessment of the efficacy
timeFrame: End of study
measure: Evaluation of the safety and tolerability
timeFrame: Baseline to end of study
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Atherton
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Escondido
country: United States
state: California
city: Fresno
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Salinas
country: United States
state: California
city: Valley Village
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Norwalk
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Boyton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Alpharetta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Blue Ridge
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Centralia
country: United States
state: Illinois
city: Slidell
country: United States
state: Louisiana
city: Bloomfield Hills
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Lawrenceville
country: United States
state: New Jersey
city: South Bound Brook
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: East Syracuse
country: United States
state: New York
city: Hewlett
country: United States
state: New York
city: Lewiston
country: United States
state: New York
city: New York
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismark
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Endwell
country: United States
state: Pennsylvania
city: Media
country: United States
state: Pennsylvania
city: Monroeville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Mt Pleasant
country: United States
state: South Carolina
city: Athens
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: West Point
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
citation: Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062.
citation: Serels SR, Toglia MR, Forero-Schwanhaeuser S, He W. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010 Oct;26(10):2277-85. doi: 10.1185/03007995.2010.509582.