Clinical trial NCT00911937: A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: incontinence OAB urgency nocturia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 963
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 study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.


Eligibility criteria: Inclusion Criteria:

* Mean urinary frequency of \>=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
* Mean number of micturition related urgency episodes \>=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating \>=3)
* Mean number of micturition related nocturnal urgency episodes \>=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of \>3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

* A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
* Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Primary outcomes:
measure: Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4
timeFrame: Baseline and Week 4
measure: Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Number of Nocturnal Micturitions Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Number of Micturition-related Urgency Episodes Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Nocturnal Frequency-urgency Sum Rating Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Frequency-urgency Sum Rating Per 24 Hours
timeFrame: Baseline
measure: Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Mean Voided Volume Per Nocturnal Micturition
timeFrame: Baseline
measure: Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12
timeFrame: Baseline and Week 12
measure: Mean Voided Volume Per Micturition
timeFrame: Baseline
measure: Change From Baseline in Mean Voided Volume Per Micturition at Week 12
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
timeFrame: Baseline
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
timeFrame: Baseline
measure: Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Goodyear
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Litchfield Park
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Roseville
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: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Tarzana
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: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Dover
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Bonita Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: DeFuniak Springs
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Destin
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: West Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Newton
country: United States
facility: Pfizer Investigational Site
state: Kansas
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: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Pratt
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Mount Sterling
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Fall River
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Hyannis
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New Bedford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Hamilton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
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: Burlington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
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: Concord
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Westerville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bridgeville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: East Greenwich
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Pawtucket
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Milan
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: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
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: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: