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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.
Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients prescribed with Fesoterodine | Patients diagnosed with Over-active bladder and prescribed with fesoterodine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | Any dose of Fesoterodine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with Over-active bladder
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary Johnston Hospital, Inc. | Tondo | Manila | 1000 | Philippines | ||
| East Avenue Medical Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine Fumarate | Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| 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 |
| 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 |
| Diliman, Quezon City |
| National Capital Region |
| 1101 |
| Philippines |
| The Medical City | Pasig | National Capital Region | 1605 | Philippines |
| St. Luke's Medical Center | Quezon City | National Capital Region | 1102 | Philippines |
| Private Clinic | Baguio City | Philippines |
| Private Clinic | Batangas | Philippines |
| Cebu Doctors Hospital, Osmena Blvd., | Cebu | Philippines |
| Private Clinic | City of Muntinlupa | Philippines |
| Davao Doctors Hospital | Davao City | Philippines |
| Davao Doctors Tower | Davao City | Philippines |
| Davao Medical School Foundation Hospital | Davao City | Philippines |
| Private Clinic | Davao City | Philippines |
| Room 120, Davao Medical School Foundation Hospital | Davao City | Philippines |
| Private Clinic | Ilocos Norte | Philippines |
| Private Clinic | La Union | Philippines |
| Private Clinic | Laguna | Philippines |
| Lucena United Doctors Hospital | Lucena City | 4301 | Philippines |
| Makati Medical Center | Makati City | 1200 | Philippines |
| Private Clinic | Makati City | Philippines |
| Room 314 Main Building | Makati City | Philippines |
| VRPMC | Mandaluyong | Philippines |
| Medical Center Manila | Manila | 1000 | Philippines |
| University of Sto. Tomas Hospital | Manila | 1000 | Philippines |
| Ospital ng Maynila Medical Center | Manila | Philippines |
| Private Clinic | Manila | Philippines |
| Santo Tomas University Hospital | Manila | Philippines |
| Private Clinic | Nueva Ecija | Philippines |
| Healthway Medical, The Block | Philippines | Philippines |
| East Avenue Medical Center | Quezon | Philippines |
| Private Clinic | Quezon | Philippines |
| St. Luke's Medical Center, North Tower, CHBC | Quezon City | 1100 | Philippines |
| Private Clinic | Quezon City | Philippines |
| Private Clinic | South Luzon | 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 | 1100 | Philippines |
| Urology Clinic | Zamboanga City | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fesoterodine Fumarate | Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
| |||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Safety population defined as all participants who received at least one dose of study medication. | Posted | Number | participants | Baseline up to 28 days after last dose |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected. | Posted | Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected. | Posted | Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected. | Posted | Week 4 and Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected. | Posted | Week 4 and Week 8 |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine Fumarate | Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity. | 0 | 508 | 21 | 508 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Non-systematic Assessment |
|
The implementation of Protocol Amendment 1 led to removal of all primary efficacy outcome measures, therefore the efficacy outcome measures were not investigated or reported.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| Title | Measurements |
|---|---|
|
| Participants with serious AEs, treatment-related |
|
| Participants with severe AEs, all-causality |
|
| Participants with severe AEs, treatment-related |
|