Clinical trial NCT00536484: Fesoterodine Flexible Dose Study
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 896
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: This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Overactive bladder symptoms for greater than or equal to 3 months.
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
* Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

* Contraindication to fesoterodine (antimuscarinics).
* Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Primary outcomes:
measure: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2 and Week 6
measure: Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale
timeFrame: Baseline and Week 12
measure: Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
timeFrame: Baseline and Week 12
measure: Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
measure: Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
timeFrame: Baseline, Week 2, Week 6 and Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Rancho Cordova
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Bonita Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Worth
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Pratt
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Bel Air
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: West Yarmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Paw Paw
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Picayune
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: New York
city: Manlius
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: State College
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Mountlake Terrace
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: