Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder
1 other identifier
observational
508
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
September 11, 2014
CompletedSeptember 11, 2014
September 1, 2014
2.7 years
November 22, 2010
September 4, 2014
September 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).
Baseline up to 28 days after last dose
Other Outcomes (4)
Number of Micturitions Per 24 Hours at Week 4 and Week 8
Week 4 and Week 8
Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8
Week 4 and Week 8
Number of UUI Episodes Per 24 Hours at Week 4 and Week 8
Week 4 and Week 8
- +1 more other outcomes
Study Arms (1)
Patients prescribed with Fesoterodine
Patients diagnosed with Over-active bladder and prescribed with fesoterodine.
Interventions
Eligibility Criteria
Patients diagnosed with Over-active bladder
You may qualify if:
- Over-active bladder
- Prescribed with Fesoterodine
You may not qualify if:
- Hypersensitivity
- Urinary retention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (37)
Mary Johnston Hospital, Inc.
Tondo, Manila, 1000, Philippines
East Avenue Medical Center
Diliman, Quezon City, National Capital Region, 1101, Philippines
The Medical City
Pasig, National Capital Region, 1605, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, 1102, Philippines
Private Clinic
Baguio City, Philippines
Private Clinic
Batangas, Philippines
Cebu Doctors Hospital, Osmena Blvd.,
Cebu, Philippines
Private Clinic
City of Muntinlupa, Philippines
Davao Doctors Hospital
Davao City, Philippines
Davao Doctors Tower
Davao City, Philippines
Davao Medical School Foundation Hospital
Davao City, Philippines
Private Clinic
Davao City, Philippines
Room 120, Davao Medical School Foundation Hospital
Davao City, Philippines
Private Clinic
Ilocos Norte, Philippines
Private Clinic
La Union, Philippines
Private Clinic
Laguna, Philippines
Lucena United Doctors Hospital
Lucena City, 4301, Philippines
Makati Medical Center
Makati City, 1200, Philippines
Private Clinic
Makati City, Philippines
Room 314 Main Building
Makati City, Philippines
VRPMC
Mandaluyong, Philippines
Medical Center Manila
Manila, 1000, Philippines
University of Sto. Tomas Hospital
Manila, 1000, Philippines
Ospital ng Maynila Medical Center
Manila, Philippines
Private Clinic
Manila, Philippines
Santo Tomas University Hospital
Manila, Philippines
Private Clinic
Nueva Ecija, Philippines
Healthway Medical, The Block
Philippines, Philippines
East Avenue Medical Center
Quezon, Philippines
Private Clinic
Quezon, Philippines
St. Luke's Medical Center, North Tower, CHBC
Quezon City, 1100, Philippines
Private Clinic
Quezon City, Philippines
Private Clinic
South Luzon, Philippines
Central Luzon Doctor's Hospital
Tarlac City, Philippines
Fatima Medical Center, Inc.
Valenzuela, Philippines
F.E.U. - Nicanor Reyes Medical Foundation Medical Center
West Fairview, Quezon City, 1100, Philippines
Urology Clinic
Zamboanga City, Philippines
Related Links
MeSH Terms
Interventions
Limitations and Caveats
The implementation of Protocol Amendment 1 led to removal of all primary efficacy outcome measures, therefore the efficacy outcome measures were not investigated or reported.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2010
First Posted
December 15, 2010
Study Start
February 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
September 11, 2014
Results First Posted
September 11, 2014
Record last verified: 2014-09