Clinical trial NCT00454740: Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
Official title: An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US
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: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes


Eligibility criteria: Inclusion Criteria:

* Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
* Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
* At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
* Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.

Exclusion Criteria:

* Previous treatment with darifenacin
* Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
* 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 as determined by the Investigator
* Uncontrolled narrow angle glaucoma, urinary or gastric retention.
* All patients with severe renal or hepatic impairment will be excluded
* Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

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: To assess the improvement in urge incontinence, frequency,nocturia, and urgency
timeFrame: Weeks 1, 4, 8 and 12
measure: Number of patients satisfied with treatment
timeFrame: Weeks 1, 4, 8 and 12
measure: Assessment of efficacy
timeFrame: End of study
measure: Evaluation of the safety and tolerability
timeFrame: Baseline to end of study
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Dinuba
country: United States
state: California
city: Glendora
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Modesto
country: United States
state: California
city: San Bernadino
country: United States
state: California
city: Torrance
country: United States
state: California
city: Upland
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: Denver
country: United States
state: Colorado
city: Farmington
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: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Margate
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St Augustine
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: Boise
country: United States
state: Idaho
city: Coeur d'Alene
country: United States
state: Idaho
city: Centralia
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kankakee
country: United States
state: Illinois
city: Niles
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Jeffersonville
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Garrison
country: United States
state: Maryland
city: St Louis
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Edison
country: United States
state: New Jersey
city: Lawrenceville
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Albany
country: United States
state: New York
city: Albany
country: United States
state: New York
city: Bayshore
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Lewiston
country: United States
state: New York
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Concord
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Springfield
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Bethlehem
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: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Aiken
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Jefferson City
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Athens
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bountiful
country: United States
state: Utah
city: Layton
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Alexandria
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Chancellor MB, Zinner N, Whitmore K, Kobashi K, Snyder JA, Siami P, Karram M, Laramee C, Capo' JP Jr, Seifeldin R, Forero-Schwanhaeuser S, Nandy I. Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011.
citation: Zinner N, Noe L, Rasouliyan L, Marshall T, Seifeldin R. Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER. Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17.
citation: Swift SE, Siami P, Forero-Schwanhaeuser S. Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study. Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003.
citation: Zinner N, Noe L, Rasouliyan L, Marshall T, Runken MC, Seifeldin R. Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis. Am J Geriatr Pharmacother. 2009 Dec;7(6):373-82. doi: 10.1016/j.amjopharm.2009.11.004.
citation: Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.