Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder
Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Bladder, Overactive
Intervention: Fesoterodine (Drug); Fesoterodine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
This is an open-label extension study intended for subjects who have previously completed
study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the
investigator as being suitable for the extended use of Fesoterodine. Data from this study
will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older
subjects from Portugal.
Clinical Details
Official title: A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean number of micturition-related urgency episodes per 24h at end of treatment. Micturition-related urgency episodes are defined as those with Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the diary.
Secondary outcome: Mean number of micturition-related urgency episodes per 24 hours at each visit (Urgency episodes are defined as those with the Urinary Sensation Scale (USS) rating of ≥3 in the diary).Mean number of severe micturition-related urgency episodes per 24 hours at each visit (severe urgency episodes are defined as those with the Urinary Sensation Scale (USS) rating ≥4). Mean number of micturitions per 24 hours at each visit (micturitions include episodes of voluntary micturition and episodes of UUI). Mean number of night-time micturitions per 24 hours at each visit. Mean number of urgency urinary incontinence (UUI) episodes per 24 hours at each visit (UUI episodes are defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary). Daily sum rating in the Urinary Sensation Scale (USS) at each visit. Percentage of patients who were incontinent at enrollment visit (at least one UUI episode during the enrollment visit period) and were dry (no UUI episodes) in the 3 days prior to each visit. UUI episodes are defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. Number of urinary incontinence pads, barrier creams and powder (for skin protection) used by subjects with UUI. Patient Perception of Bladder Condition (PPBC) (one question). Patient Perception of Urgency Scale (PPUS) (one question). Overactive Bladder Questionnaire (OAB-q) (33 questions). o Total score of OAB-q at each visit. o Total score of each domain of OAB-q at each visit. Overactive Bladder Satisfaction Questionnaire (OAB-s) (4 questions). o Scores from the selected items at each visit. King's Health Questionnaire (KHQ) 21 questions) and used to compare the performance of the KHQ with the other QOL instruments). o Total score of each domain of KHQ at each visit. Incidence, severity, and relatedness to treatment of all reported and treatment emergent Adverse Events and withdrawals from the trial due to Adverse Events.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
- Subjects must be recommended for inclusion by the investigator
Exclusion Criteria:
- Conditions or states excluding use of fesoterodine e. g. contraindication to
fesoterodine
- Predominant stress incontinence as determined by the investigator
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Centro de Avaliação Geriátrica, Lisboa 1990-273, Portugal; Recruiting
José Palma dos Reis, MD, Phone: +351 966039945
Hospital de São João, Porto 4200-319, Portugal; Recruiting
Teresa Mascarenhas, PhD, MD, Phone: +351 913231207
Hospital de São João, Porto 4200-319, Portugal; Recruiting
Francisco Cruz, PhD, MD, Phone: +351 225512100
Hospital Ordem do Carmo, Porto 4099-005, Portugal; Recruiting
Miguel Guimarães, Phone: +351 936050472
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2010
Last updated: December 6, 2011
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