Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01260311
First received: November 22, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Over Active Bladder
Drug: Fesoterodine
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety. [ Time Frame: Week 4 and 8 visit. ] [ Designated as safety issue: Yes ]
  • Number of micturitions per 24 hours as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ] [ Designated as safety issue: No ]
  • Number of urgency episodes per 24 hours as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ] [ Designated as safety issue: No ]
  • Number of urgency urinary incontinence (UUI) episodes per 24 hours as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ] [ Designated as safety issue: No ]
  • Patient perception of bladder condition as a measure of efficacy. [ Time Frame: Week 4 and 8 visit. ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: February 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed with Fesoterodine
Patients diagnosed with Over-active bladder and prescribed with fesoterodine.
Drug: Fesoterodine
Any dose of Fesoterodine
Other Name: Toviaz

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with Over-active bladder

Criteria

Inclusion Criteria:

  • Over-active bladder
  • Prescribed with Fesoterodine

Exclusion Criteria:

  • Hypersensitivity
  • Urinary retention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260311

Locations
Philippines
Mary Johnston Hospital, Inc.
Tondo, Manila, Philippines, 1000
East Avenue Medical Center
Diliman, Quezon City, Metro Manila, Philippines, 1101
The Medical City
Pasig City, Metro Manila, Philippines, 1605
St. Luke's Medical Center
Quezon City, Metro Manila, Philippines, 1102
Private Clinic
Baguio City, Philippines
Private Clinic
Batangas, Philippines
Cebu Doctors Hospital, Osmena Blvd.,
Cebu, Philippines
Davao Doctors Hospital
Davao, Philippines
Davao Medical School Foundation Hospital
Davao, Philippines
Private Clinic
Davao City, Philippines
Davao Doctors Tower
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, Philippines, 4301
Room 314 Main Building
Makati City, Philippines
Makati Medical Center
Makati City, Philippines, 1200
Private Clinic
Makati City, Philippines
VRPMC
Mandaluyong, Philippines
Santo Tomas University Hospital
Manila, Philippines
University of Sto. Tomas Hospital
Manila, Philippines, 1000
Private Clinic
Manila, Philippines
Ospital ng Maynila Medical Center
Manila, Philippines
Medical Center Manila
Manila, Philippines, 1000
Private Clinic
Muntinlupa City, Philippines
Private Clinic
Nueva Ecija, Philippines
Healthway Medical, The Block
Philippines, Philippines
Private Clinic
Quezon, Philippines
East Avenue Medical Center
Quezon, Philippines
St. Luke's Medical Center, North Tower, CHBC
Quezon City, Philippines, 1100
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, Philippines, 1100
Urology Clinic
Zamboanga City, Philippines
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01260311     History of Changes
Other Study ID Numbers: A0221085
Study First Received: November 22, 2010
Last Updated: December 4, 2013
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Pfizer:
Observational

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014