Clinical trial NCT01260311: Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
Official title: Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Over Active Bladder
Keywords: Observational
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Over-active bladder

Brief summary: This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.

Detailed description: Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Over-active bladder
* Prescribed with Fesoterodine

Exclusion Criteria:

* Hypersensitivity
* Urinary retention

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
timeFrame: Baseline up to 28 days after last dose
Secondary outcomes:
Other outcomes:
measure: Number of Micturitions Per 24 Hours at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Number of UUI Episodes Per 24 Hours at Week 4 and Week 8
timeFrame: Week 4 and Week 8
measure: Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8
timeFrame: Week 4 and Week 8
Locations:
city: Tondo
country: Philippines
facility: Mary Johnston Hospital, Inc.
state: Manila
city: Diliman, Quezon City
country: Philippines
facility: East Avenue Medical Center
state: Metro Manila
city: Pasig City
country: Philippines
facility: The Medical City
state: Metro Manila
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: Metro Manila
city: Baguio City
country: Philippines
facility: Private Clinic
city: Batangas
country: Philippines
facility: Private Clinic
city: Cebu
country: Philippines
facility: Cebu Doctors Hospital, Osmena Blvd.,
city: Davao City
country: Philippines
facility: Davao Doctors Tower
city: Davao City
country: Philippines
facility: Private Clinic
city: Davao City
country: Philippines
facility: Room 120, Davao Medical School Foundation Hospital
city: Davao
country: Philippines
facility: Davao Doctors Hospital
city: Davao
country: Philippines
facility: Davao Medical School Foundation Hospital
city: Ilocos Norte
country: Philippines
facility: Private Clinic
city: La Union
country: Philippines
facility: Private Clinic
city: Laguna
country: Philippines
facility: Private Clinic
city: Lucena City
country: Philippines
facility: Lucena United Doctors Hospital
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Makati City
country: Philippines
facility: Private Clinic
city: Makati City
country: Philippines
facility: Room 314 Main Building
city: Mandaluyong
country: Philippines
facility: VRPMC
city: Manila
country: Philippines
facility: Medical Center Manila
city: Manila
country: Philippines
facility: University of Sto. Tomas Hospital
city: Manila
country: Philippines
facility: Ospital ng Maynila Medical Center
city: Manila
country: Philippines
facility: Private Clinic
city: Manila
country: Philippines
facility: Santo Tomas University Hospital
city: Muntinlupa City
country: Philippines
facility: Private Clinic
city: Nueva Ecija
country: Philippines
facility: Private Clinic
city: Philippines
country: Philippines
facility: Healthway Medical, The Block
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center, North Tower, CHBC
city: Quezon City
country: Philippines
facility: Private Clinic
city: Quezon
country: Philippines
facility: East Avenue Medical Center
city: Quezon
country: Philippines
facility: Private Clinic
city: South Luzon
country: Philippines
facility: Private Clinic
city: Tarlac City
country: Philippines
facility: Central Luzon Doctor's Hospital
city: Valenzuela
country: Philippines
facility: Fatima Medical Center, Inc.
city: West Fairview, Quezon City
country: Philippines
facility: F.E.U. - Nicanor Reyes Medical Foundation Medical Center
city: Zamboanga City
country: Philippines
facility: Urology Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: