A LOCAL, MULTICENTRE, OPEN-LABEL, EXTENSION TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER
- Conditions
- Treatment of overactive bladder with symptoms of frequency, urgency, and urgencyincontinence (Some patients will also have urgency urinary incontinence (UUI)).MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2010-018254-12-PT
- Lead Sponsor
- Pfizer, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
1. Completed the A0221045 trial and has been recommended by the investigator for extended use of Fesoterodine
2. Able and willing to complete all the trial related questionnaires and comply with scheduled clinic visits and clinical trial procedures.
3. Capable of understanding and has signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any condition that would contraindicate their usage of Fesoterodine including: hypersensitivity to the active substance (Fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
2. Predominant Stress Incontinence. Stress urinary incontinence as determined/estimated by the investigator.
3. Participated in any clinical trial other than A0221045 or received any other investigational drug within 4 weeks prior to enrollment Visit.
4. Other severe or acute medical condition (including newly diagnosed diabetes mellitus or newly diagnosed hypertension requiring treatment, or major hematological or cardiovascular conditions) or psychological condition or social circumstances that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of the study results or may impair ability to participate reliably in the trial, or may increase the risk to themselves or others as judged by the investigator.
5. Abuse of alcohol and/or any other drug in the opinion of the investigator.
6. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term efficacy, in terms of maintenance of Fesoterodine effect on urgency episode frequency in elderly subjects with OAB.;Secondary Objective: • To assess the long-term safety and tolerability of Fesoterodine in elderly subjects with OAB.<br>• To assess the long-term efficacy, in terms of maintenance of Fesoterodine effect on other OAB symptoms, and on patient reported outcomes, in elderly subjects with OAB.<br>;Primary end point(s): • 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 Measures
Name Time Method