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

Completed

• Conditions: Over Active Bladder
• Interventions: Drug: Fesoterodine

• Registration Number: NCT01260311
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Study Start: 2011-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-09
• Results First Submitted: 2014-09-04
• Results First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Results First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

• Over-active bladder
• Prescribed with Fesoterodine

Exclusion Criteria

• Hypersensitivity
• Urinary retention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed with Fesoterodine	Fesoterodine	Patients diagnosed with Over-active bladder and prescribed with fesoterodine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment	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).

Trial Locations

Locations (24)

Mary Johnston Hospital, Inc.; 🇵🇭 Tondo, Manila, Philippines

The Medical City; 🇵🇭 Pasig City, Metro Manila, Philippines

St. Luke's Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

Cebu Doctors Hospital, Osmena Blvd.,; 🇵🇭 Cebu, Philippines

Santo Tomas University Hospital; 🇵🇭 Manila, Philippines

East Avenue Medical Center; 🇵🇭 Quezon, Philippines

Private Clinic; 🇵🇭 South Luzon, Philippines

Room 120, Davao Medical School Foundation Hospital; 🇵🇭 Davao City, Philippines

Davao Doctors Tower; 🇵🇭 Davao City, Philippines

Davao Medical School Foundation Hospital; 🇵🇭 Davao, Philippines

Lucena United Doctors Hospital; 🇵🇭 Lucena City, Philippines

Davao Doctors Hospital; 🇵🇭 Davao, Philippines

Makati Medical Center; 🇵🇭 Makati City, Philippines

VRPMC; 🇵🇭 Mandaluyong, Philippines

Room 314 Main Building; 🇵🇭 Makati City, Philippines

University of Sto. Tomas Hospital; 🇵🇭 Manila, Philippines

Medical Center Manila; 🇵🇭 Manila, Philippines

Ospital ng Maynila Medical Center; 🇵🇭 Manila, Philippines

Healthway Medical, The Block; 🇵🇭 Philippines, Philippines

St. Luke's Medical Center, North Tower, CHBC; 🇵🇭 Quezon City, 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

Urology Clinic; 🇵🇭 Zamboanga City, Philippines