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

Over Active Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260311
• Other study ID #: A0221085
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: September 4, 2014
• Start date: February 2011
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over-active bladder

• Prescribed with Fesoterodine

Exclusion Criteria:

• Hypersensitivity

• Urinary retention

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Over Active Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine
Any dose of Fesoterodine

Locations

Country	Name	City	State
Philippines	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	Davao Doctors Tower	Davao City
Philippines	Private Clinic	Davao City
Philippines	Room 120, Davao Medical School Foundation Hospital	Davao City
Philippines	East Avenue Medical Center	Diliman, Quezon City	Metro Manila
Philippines	Private Clinic	Ilocos Norte
Philippines	Private Clinic	La Union
Philippines	Private Clinic	Laguna
Philippines	Lucena United Doctors Hospital	Lucena City
Philippines	Makati Medical Center	Makati City
Philippines	Private Clinic	Makati City
Philippines	Room 314 Main Building	Makati City
Philippines	VRPMC	Mandaluyong
Philippines	Medical Center Manila	Manila
Philippines	Ospital ng Maynila Medical Center	Manila
Philippines	Private Clinic	Manila
Philippines	Santo Tomas University Hospital	Manila
Philippines	University of Sto. Tomas Hospital	Manila
Philippines	Private Clinic	Muntinlupa City
Philippines	Private Clinic	Nueva Ecija
Philippines	The Medical City	Pasig City	Metro Manila
Philippines	Healthway Medical, The Block	Philippines
Philippines	East Avenue Medical Center	Quezon
Philippines	Private Clinic	Quezon
Philippines	Private Clinic	Quezon City
Philippines	St. Luke's Medical Center	Quezon City	Metro Manila
Philippines	St. Luke's Medical Center, North Tower, CHBC	Quezon City
Philippines	Private Clinic	South Luzon
Philippines	Central Luzon Doctor's Hospital	Tarlac City
Philippines	Mary Johnston Hospital, Inc.	Tondo	Manila
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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Micturitions Per 24 Hours at 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	No
Other	Number of Urgency Episodes Per 24 Hours at 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	No
Other	Number of UUI Episodes Per 24 Hours at 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	No
Other	Patient Perception of Bladder Condition (PPBC) at 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	No
Primary	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	Yes

External Links

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