Clinical trial NCT00444925: Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)
Official title: 12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 1712
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: To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Eligibility criteria: Inclusion Criteria:

* Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency \>= 8 per day and urgency urinary incontinence \>=1 per day

Exclusion Criteria:

* Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Primary outcomes:
measure: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
timeFrame: Baseline, Week 1, Week 4
measure: Percent Change From Baseline of UUI Episodes Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Mean Voided Volume Per Micturition.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Percent Change From Baseline of Micturitions Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Percent Change From Baseline of Urgency Episodes Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Patient Perception of Bladder Condition (PPBC).
timeFrame: Baseline, Week 1, Week, 4, Week 12
measure: Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
timeFrame: Baseline, Week 1, Week 4, Week 12
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
timeFrame: Baseline, Week 12
measure: Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Orangevale
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Wellington
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: Sandpoint
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Illinois
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: Shrevport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: Burlington
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: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Milan
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Provo
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Kortrijk
country: Belgium
facility: Pfizer Investigational Site
city: Tessenderlo
country: Belgium
facility: Pfizer Investigational Site
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Saint John
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montréal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Rancagua
country: Chile
facility: Pfizer Investigational Site
state: VI Región
city: Puerto Montt
country: Chile
facility: Pfizer Investigational Site
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Alajuela
country: Costa Rica
facility: Pfizer Investigational Site
city: Cartago
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Jablonec nad Nisou
country: Czech Republic
facility: Pfizer Investigational Site
city: Jindrichuv Hradec
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Aarhus N
country: Denmark
facility: Pfizer Investigational Site
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Kolding
country: Denmark
facility: Pfizer Investigational Site
city: Nykoebing Falster
country: Denmark
facility: Pfizer Investigational Site
city: Roskilde
country: Denmark
facility: Pfizer Investigational Site
city: Ahaus
country: Germany
facility: Pfizer Investigational Site
city: Alzey
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Krumbach
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Muelheim a.d. Ruhr
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Rosenheim
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Attiki
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
state: Ipiros
city: Rio, Patras
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Pfizer Investigational Site
city: Szeged
country: Hungary
facility: Pfizer Investigational Site
city: Szentes
country: Hungary
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Vellore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Latina
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Batu Caves
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Lysaker
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Sandnes
country: Norway
facility: Pfizer Investigational Site
city: Surco
country: Peru
facility: Pfizer Investigational Site
state: Lima
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Arad
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Sibiu
country: Romania
facility: Pfizer Investigational Site
city: Timisoara
country: Romania
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
state: Russia
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
state: Russia
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng Province
city: Vosloorus
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa Zulu Natal
city: Pietermaritzburg
country: South Africa
facility: Pfizer Investigational Site
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Getafe
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Huskvarna
country: Sweden
facility: Pfizer Investigational Site
city: Lulea
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Frauenfeld
country: Switzerland
facility: Pfizer Investigational Site
city: Luzern 16
country: Switzerland
facility: Pfizer Investigational Site
city: Niao-Sung Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Kaohsiung
city: Hualien
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung City
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Chernivtsi
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
citation: Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.