Treatment of overactive bladder with symptoms of frequency, urgency, and urgency incontinence. MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: Fesoterodine fumarate
Product Code: PF-00695838
Pharmaceutical Form: Prolonged-release tablet
CAS Number: 286930-03-8
Current Sponsor code: PF-00695838
Other descriptive name: Fesoterodi
Sponsors
Pfizer Inc. NYO-685-21-14,685 3rd Avenue, NEW YORK, NY 10017. US
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial: 1. Male or female outpatients = 18 years old. 2. Overactive bladder symptoms (subject-reported) for = 3 months prior to screening/enrolment visit (visit 1). 3. Reported at least an average of 1 UUI episode per 24 hours in the 3-day micturition diary prior to the randomization/baseline visit (visit 2). 4. Mean urinary frequency of = 8 micturitions per 24 hours as verified by the micturition diary prior to randomization/baseline visit (visit 2). 5. Able and willing to complete the micturition diaries and all trial related questionnaires and comply with scheduled clinic visits and clinical trial procedures. 6. Capability of understanding and having 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
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 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. Clinically significant hepatic or renal disease, and/or with a screening test of AST, ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal range (ULN). 3. Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease. 4. Stage 3 or greater pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure). 5. History of lower urinary tract surgery (e.g., incontinence surgery or surgery to reduce prostate size) within the past 6 months. 6. A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia, or bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor, radiation cystitis, genitourinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia. 7. Previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline. 8. Use of an indwelling catheter or an intermittent self-catheterization program. 9. Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. 10. Polyuria (>3000mL/24h) or a voided volume >500mL for any micturition during the runin period. 11. Urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year. 12. Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of visit 1. 13. Treatment with antimuscarinic OAB medication within 2 weeks prior to visit 1; the antimuscarinic OAB medication may include: • darifenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium 14. Expectation of initiating treatment during the trial with: • Any drug treatment for overactive bladder • Any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects. 15. Intermittent or unstable use of diuretics throughout trial duration. Treatment with diuretics initiated within 2 weeks prior to visit 1 is not permitted. 16. Treatment with potent CYP3A4 inhibitors, such as azole antifungal agents (eg, ketoconazole, itraconazole, miconazole), macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), vinblastine, and protease inhibitors, within 2 weeks prior to visit 1 or the expectation to start such a treatment during the trial. 17. Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) within 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of fesoterodine to placebo and tolterodine ER in subjects with overactive bladder after 12 weeks of treatment.;Secondary Objective: 1. To compare the effect of fesoterodine to placebo on patient reported outcomes in subjects with overactive bladder after 12 weeks of treatment. 2. To compare the efficacy of fesoterodine 4mg QD to placebo in subjects with overactive bladder after 1 week of treatment. 3. To summarize safety data for 12 weeks of treatment with either fesoterodine, tolterodine, or placebo in subjects with overactive bladder.;Primary end point(s): Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at week 12 relative to the baseline (UUI episodes are defined as those with Bladder Sensation Scale rating of 5 in the diary) | — |
Countries
Czech Republic, Germany, Greece, Hungary, Italy, Spain, Sweden
Outcome results
None listed