Clinical trial NCT00366002: Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
Official title: A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder (OAB)
Keywords: Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2006-08-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.


Eligibility criteria: Inclusion Criteria:

* • Symptoms of OAB for at least six months prior to randomization

  * ≥ 8 micturitions on average/24 hours
  * ≥ 1 urgency episodes on average/24 hours
  * with or without UUIE

    * Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken.
    * Patients without prior darifenacin treatment

Exclusion Criteria:

* • A mean daily urinary volume \>3000 mL or a mean volume voided/micturition of \>300 mL as verified in the micturition diary for two consecutive days prior to Baseline

  * Males with post-void residual (PVR) urinary volume \>200 mL at Baseline
  * Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator
  * Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator

Other protocol-defined inclusion / exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC).
Secondary outcomes:
measure: Patient's perception of outcome using the PPBC questionnaire at Week 7.
measure: Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13.
measure: Assessment of efficacy of darifenacin with respect to change from baseline in:
measure: Number of micturitions per day at Weeks 7 and 13
measure: Number of urgency episodes per day at Weeks 7 and 13
measure: Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13
measure: Assessment of safety and tolerability
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: Chandler
country: United States
facility: Investigative Site
state: Arizona
city: Mesa
country: United States
facility: Investigative Site
state: Arizona
city: Sierra Vista
country: United States
facility: Investigative Site
state: Arizona
city: Tempe
country: United States
facility: Investigative Site
state: Arizona
city: Atherton
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Newport Beach
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Temecula
country: United States
facility: Investigative Site
state: California
city: Torrance
country: United States
facility: Investigative Site
state: California
city: Upland
country: United States
facility: Investigative Site
state: California
city: Aurora
country: United States
facility: Investigative Site
state: Colorado
city: Littleton
country: United States
facility: Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Investigative Site
state: Colorado
city: Hollywood
country: United States
facility: Investigative Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Investigative Site
state: Florida
city: Ocala
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigative Site
state: Florida
city: Weston
country: United States
facility: Investigative Site
state: Florida
city: Alpharetta
country: United States
facility: Investigative Site
state: Georgia
city: Atlanta
country: United States
facility: Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Investigative Site
state: Georgia
city: Roswell
country: United States
facility: Investigative Site
state: Georgia
city: Snellville
country: United States
facility: Investigative Site
state: Georgia
city: Melrose Park
country: United States
facility: Investigative Site
state: Illinois
city: O'Fallon
country: United States
facility: Investigative Site
state: Illinois
city: Peoria
country: United States
facility: Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Investigative Site
state: Indiana
city: Greenwood
country: United States
facility: Investigative Site
state: Indiana
city: Topeka
country: United States
facility: Investigative Site
state: Kansas
city: Milford
country: United States
facility: Investigative Site
state: Massachusetts
city: Watertown
country: United States
facility: Investigative Site
state: Massachusetts
city: Flint
country: United States
facility: Investigative Site
state: Michigan
city: Saint Joseph
country: United States
facility: Investigative Site
state: Michigan
city: Chesterfield
country: United States
facility: Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Investigative Site
state: Missouri
city: Lincoln
country: United States
facility: Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Investigative Site
state: Nebraska
city: Lawrenceville
country: United States
facility: Investigative Site
state: New Jersey
city: West Orange
country: United States
facility: Investigative Site
state: New Jersey
city: Albany
country: United States
facility: Investigative Site
state: New York
city: Garden City
country: United States
facility: Investigative Site
state: New York
city: Latham
country: United States
facility: Investigative Site
state: New York
city: Mineola
country: United States
facility: Investigative Site
state: New York
city: New Hartford
country: United States
facility: Investigative Site
state: New York
city: Poughkeepsie
country: United States
facility: Investigative Site
state: New York
city: Troy
country: United States
facility: Investigative Site
state: New York
city: Williamsville
country: United States
facility: Investigative Site
state: New York
city: Burlington
country: United States
facility: Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Investigative Site
state: North Carolina
city: Concord
country: United States
facility: Investigative Site
state: North Carolina
city: Hickory
country: United States
facility: Investigative Site
state: North Carolina
city: High Point
country: United States
facility: Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Investigative Site
state: North Carolina
city: Winston Salem
country: United States
facility: Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Bethany
country: United States
facility: Investigative Site
state: Oklahoma
city: Edmond
country: United States
facility: Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: Investigative Site
state: Oregon
city: Springfield
country: United States
facility: Investigative Site
state: Oregon
city: Pittsburgh
country: United States
facility: Investigative Site
state: Pennsylvania
city: Amarillo
country: United States
facility: Investigative Site
state: Texas
city: Corsicana
country: United States
facility: Investigative Site
state: Texas
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Investigative Site
state: Texas
city: Bountiful
country: United States
facility: Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
city: Sandy
country: United States
facility: Investigative Site
state: Utah
city: Richmond
country: United States
facility: Investigative Site
state: Virginia
city: Everett
country: United States
facility: Investigative Site
state: Washington
city: Lakewood
country: United States
facility: Investigative Site
state: Washington
city: Mountlake Terrace
country: United States
facility: Investigative Site
state: Washington
city: Seattle
country: United States
facility: Investigative Site
state: Washington
city: Vancouver
country: United States
facility: Investigative Site
state: Washington
city: Milwaukee
country: United States
facility: Investigative Site
state: Wisconsin
Study officials:
affiliation: NPC
name: Novartis Pharmaceutical Corporation
role: STUDY_CHAIR
References:
citation: Zinner N, Kobashi K, Koochaki P, Fix D, Egermark M. Patient satisfaction with the benefits of overactive bladder treatment: exploration of influencing factors and development of a satisfaction assessment instrument. Neurourol Urodyn. 2011 Jan;30(1):62-8. doi: 10.1002/nau.20890. Epub 2010 Sep 21.
citation: Zinner N, Kobashi KC, Ebinger U, Viegas A, Egermark M, Quebe-Fehling E, Koochaki P. Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. Int J Clin Pract. 2008 Nov;62(11):1664-74. doi: 10.1111/j.1742-1241.2008.01893.x. Epub 2008 Sep 22.