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

September 4, 2014 updated by: Pfizer

Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Over-active bladder

Description

Inclusion Criteria:

  • Over-active bladder
  • Prescribed with Fesoterodine

Exclusion Criteria:

  • Hypersensitivity
  • Urinary retention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients prescribed with Fesoterodine
Patients diagnosed with Over-active bladder and prescribed with fesoterodine.
Drug: Fesoterodine
Any dose of Fesoterodine
Other Names:
  • Toviaz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
Time Frame: Baseline up to 28 days after last dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Micturitions Per 24 Hours at Week 4 and Week 8
Time Frame: Week 4 and Week 8
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Week 4 and Week 8
Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8
Time Frame: Week 4 and Week 8
Urgency episodes were defined as micturitions with USS rating of greater than or equal to (>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 4 and Week 8
Number of UUI Episodes Per 24 Hours at Week 4 and Week 8
Time Frame: Week 4 and Week 8
UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Week 4 and Week 8
Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8
Time Frame: Week 4 and Week 8
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Week 4 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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