overactive bladder (OAB) MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Trade Name: Toviaz
Product Name: Fesoterodine Fumarate
Product Code: PF-00695838
Pharmaceutical Form: Tablet
CAS Number: 286930-03-8
Current Sponsor code: PF-00695838
Other descriptive name: Fesotero
Sponsors
Pfizer Inc. 235 East 42nd Street, NEW YORK, NY 10017. US
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged 40 years and above 2. On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1) 3. Persistent symptoms of OAB as verified by the screening 3-day bladder diary, defined by: a. Mean urinary frequency =8 times/24 hours b. Mean number of micturition-related urgency episodes =3 episode/24 hours (with a Urinary Sensation Scale rating of =3 marked for the corresponding micturition in the bladder diary) 4. A rating of the bladder condition at Baseline (visit 2) prior to randomization as “Some Moderate Problems,” “Severe Problems,” or “Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire 5. The ability and willingness to correctly complete the bladder diary and various questionnaires, comply with scheduled visits and trial procedures 6. The capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks 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: 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. Poor tolerability to the ongoing alpha blocker treatment or deemed unsuitable or unlikely to continue alpha blocker treatment at the current dose for the duration of the study by the investigator according to the approved product labeling for each drug in each country 3. Previous history of acute urinary retention requiring catheterization or existing clinically significant bladder outlet obstruction in the judgment of the investigator 4. A post void residual urinary volume greater than 200 ml at Baseline (Visit 2) 5. Clinically significant hepatic or renal disease, and/or with a screening test of AST, ALT, Alk Phos, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal (ULN) 6. Known history or evidence at screening visit of symptomatic postural hypotension or syncope while on alpha blocker(s) (a measured reduction of greater than 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure on standing with relevant postural symptoms) 7. History, evidence or suspicion of prostate cancer. A total prostate specific antigen (total PSA) value of greater than 10 ng/ml at screening would exclude subjects, unless documented evidence can be provided to rule out prostate malignancy 8. Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease 9. A known history of 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 10. A known history of uninvestigated hematuria, interstitial cystitis, genitourinary tuberculosis, bladder calculi or detrusor-sphincter dyssynergia 11. History of radiation treatment to pelvic organs or external genitalia for any reason 12. Previous history of prostatic surgery/intervention (including minimally invasive treatments), or other major urethral and/or bladder surgery 13. Urinary tract infection (UTI) as shown by the results of the urinalysis at Screening or recurrent UTI defined as treatment for UTI >3 times in the last year 14. Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Visit 1, or the expectation to start such a treatment during the trial 15. Treatment with hepatic enzyme inducers, eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort, within 2 weeks prior to Visit 1, or the expectation to start such a treatment during the trial 16. Treatment with the following medications within 3 weeks prior to Visit 1, or the expectation to start such a treatment during the trial • Any drug treatment for overactive bladder, including antimuscarinic OAB medications • Any drugs with significant anticholinergic or antispasmodic effects 17. Treatment with a 5-alpha reductase inhibitor initiated within 6 months prior to Screening (Visit 1), or the expectation to start such a treatment during the trial 18. Treatment with any medication for BPH other than alpha blocker and 5-alpha reductase inhibitor, eg, saw palmetto, if started less
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of fesoterodine on OAB symptom improvement, vs. placebo, as an “add-on” therapy, in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving alpha-blocker monotherapy for lower urinary tract symptoms (LUTS) at a stable dose for at least 6 weeks.;Secondary Objective: 1. To evaluate the effect of “add-on” fesoterodine on international prostate symptom scale (IPSS) vs. placebo. 2. To evaluate the effect of “add-on” fesoterodine on patient reported outcomes, vs. placebo. 3. To evaluate the safety and tolerability of “add-on” fesoterodine.;Primary end point(s): Numeric change of micturition-related urgency episodes per 24 hours at Week 12 relative to baseline (micturition-related urgency episodes are defined as those with Urinary Sensation Scale rating of =3 marked for the corresponding micturition in the diary) | — |
Countries
Germany, Greece, Netherlands, Spain, Sweden
Outcome results
None listed