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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01260311
First received: November 22, 2010
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 3000
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260311

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Philippines
Mary Johnston Hospital, Inc. Recruiting
Tondo, Manila, Philippines, 1000
East Avenue Medical Center Recruiting
Diliman, Quezon City, Metro Manila, Philippines, 1101
The Medical City Recruiting
Pasig City, Metro Manila, Philippines, 1605
St. Luke's Medical Center Recruiting
Quezon City, Metro Manila, Philippines, 1102
Private Clinic Recruiting
Baguio City, Philippines
Private Clinic Recruiting
Batangas, Philippines
Cebu Doctors Hospital, Osmena Blvd., Recruiting
Cebu, Philippines
Davao Medical School Foundation Hospital Recruiting
Davao, Philippines
Davao Doctors Hospital Recruiting
Davao, Philippines
Private Clinic Recruiting
Davao City, Philippines
Davao Doctors Tower Recruiting
Davao City, Philippines
Room 120, Davao Medical School Foundation Hospital Recruiting
Davao City, Philippines
Private Clinic Recruiting
Ilocos Norte, Philippines
Private Clinic Recruiting
La Union, Philippines
Private Clinic Recruiting
Laguna, Philippines
Lucena United Doctors Hospital Recruiting
Lucena City, Philippines, 4301
Room 314 Main Building Recruiting
Makati City, Philippines
Makati Medical Center Recruiting
Makati City, Philippines, 1200
Private Clinic Recruiting
Makati City, Philippines
VRPMC Recruiting
Mandaluyong, Philippines
Private Clinic Recruiting
Manila, Philippines
Medical Center Manila Recruiting
Manila, Philippines, 1000
Santo Tomas University Hospital Recruiting
Manila, Philippines
University of Sto. Tomas Hospital Recruiting
Manila, Philippines, 1000
Ospital ng Maynila Medical Center Recruiting
Manila, Philippines
Private Clinic Recruiting
Muntinlupa City, Philippines
Private Clinic Recruiting
Nueva Ecija, Philippines
Healthway Medical, The Block Recruiting
Philippines, Philippines
East Avenue Medical Center Recruiting
Quezon, Philippines
Private Clinic Recruiting
Quezon, Philippines
Private Clinic Recruiting
Quezon City, Philippines
St. Luke's Medical Center, North Tower, CHBC Recruiting
Quezon City, Philippines, 1100
Private Clinic Recruiting
South Luzon, Philippines
Central Luzon Doctor's Hospital Recruiting
Tarlac City, Philippines
Fatima Medical Center, Inc. Recruiting
Valenzuela, Philippines
F.E.U. - Nicanor Reyes Medical Foundation Medical Center Recruiting
West Fairview, Quezon City, Philippines, 1100
Urology Clinic Recruiting
Zamboanga City, Philippines
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: May 1, 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
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013