Over Active BladderNCT01260311
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
An observational study of Over Active Bladder, run by Pfizer at 37 sites in Philippines.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Over Active Bladder
- What is being tested?
- Fesoterodine
- How many people
- 508 participants
- Where
- 37 sitesPhilippines
- Study dates
- Feb 2011to Oct 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Over-active bladder
Who may be able to join
- Over-active bladder
- Prescribed with Fesoterodine
Who cannot join
- Hypersensitivity
- Urinary retention
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Philippines37 sites
Private Clinic
Baguio City
Private Clinic
Batangas
Cebu Doctors Hospital, Osmena Blvd.,
Cebu
Private Clinic
City of Muntinlupa
Davao Doctors Hospital
Davao City
Davao Doctors Tower
Davao City
Davao Medical School Foundation Hospital
Davao City
Private Clinic
Davao City
Room 120, Davao Medical School Foundation Hospital
Davao City
East Avenue Medical Center
Diliman, Quezon City, National Capital Region, 1101
Private Clinic
Ilocos Norte
Private Clinic
La Union
Private Clinic
Laguna
Lucena United Doctors Hospital
Lucena City, 4301
Makati Medical Center
Makati City, 1200
Private Clinic
Makati City
Room 314 Main Building
Makati City
VRPMC
Mandaluyong
Medical Center Manila
Manila, 1000
University of Sto. Tomas Hospital
Manila, 1000
Ospital ng Maynila Medical Center
Manila
Private Clinic
Manila
Santo Tomas University Hospital
Manila
Private Clinic
Nueva Ecija
The Medical City
Pasig, National Capital Region, 1605
Healthway Medical, The Block
Philippines
East Avenue Medical Center
Quezon
Private Clinic
Quezon
St. Luke's Medical Center
Quezon City, National Capital Region, 1102
St. Luke's Medical Center, North Tower, CHBC
Quezon City, 1100
Private Clinic
Quezon City
Private Clinic
South Luzon
Central Luzon Doctor's Hospital
Tarlac City
Mary Johnston Hospital, Inc.
Tondo, Manila, 1000
Fatima Medical Center, Inc.
Valenzuela
F.E.U. - Nicanor Reyes Medical Foundation Medical Center
West Fairview, Quezon City, 1100
Urology Clinic
Zamboanga City
About this study
Official title: 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.
Read the detailed description
Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
- Conditions
- Over Active Bladder
- Being tested
- Fesoterodine
- Keywords
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Also called Toviaz
Any dose of Fesoterodine
| Study group | Role | What they receive |
|---|---|---|
| Patients prescribed with Fesoterodine | Patients diagnosed with Over-active bladder and prescribed with fesoterodine. Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline up to 28 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Over Active BladderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260311
- Sponsor's protocol ID
- A0221085
- Status last verified
- Sep 2014
- First submitted
- 22 Nov 2010
- Last updated
- 11 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder
- ClinicalTrials.gov ID
- NCT01260311
- Acronym / sponsor ID
- A0221085
- Conditions
- Over Active Bladder
- Keywords
- Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed with Fesoterodine | – | Drug: FesoterodinePatients diagnosed with Over-active bladder and prescribed with fesoterodine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Over-active bladder
Key inclusion criteria (2 listed)
- Over-active bladder
- Prescribed with Fesoterodine
Key exclusion criteria (2 listed)
- Hypersensitivity
- Urinary retention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FesoterodineAlso: ToviazAny dose of Fesoterodine | Drug | Patients prescribed with Fesoterodine |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Over Active Bladder
Enrolling by invitationObservational study
Autologous Platelet Concentrate Bladder Injection for Refractory Overactive Bladder
Over Active Bladder
Recruiting
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Over Active Bladder, Urinary Incontinence (UI)
Not yet recruiting
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Over Active Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Over Active Bladder, run by Pfizer at 37 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment (time frame: Baseline up to 28 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.