Overactive bladder (OAB)
Conditions
Interventions
Trade Name: EMSELEX 7.5 prolonged-release tablets
Product Name: EMSELEX 7.5 mg
Product Code: DAR328A
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Prolonged-release
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 65 years and over 2) Give written informed consent by signing and dating an informed consent form prior to prior to initiation of any study-related activities 3) Capable of independently completing the diary. At baseline (Visit 3), at least 5 days of the 7 day diary need to be completed for patients to be considered for randomization. 4) Capable of independent toileting 5) Symptoms of OAB for at least six months prior to Visit 3 6) Symptoms of OAB during the 7 day diary period immediately preceding Visit 3: • = 1 UUIE on average per day and • = 10 episodes of micturition on average per day 7) A Body Mass Index (BMI) between 18.50 kg/m2 - 34.99 kg/m2, inclusive Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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) Treatment 2 weeks prior to Visit 2 with drugs known to mainly affect the urinary bladder function (e.g. anticholinergics, antispasmodics, etc.) or the external urethral sphincter (e.g., duloxetine). 2) A mean daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization 3) Clinically significant stress urinary incontinence as determined by the investigator 4) Clinically significant bladder outlet obstruction as determined by investigator 5) Post-void residual (PVR) urinary volume > 100 ml at Visit 3 as assessed by ultrasound or assessment perfomed by catheterization in female 6) Any clinically significant congenital or acquired disorder of the urinary tract or any urinary bladder dysfunction (other than OAB) 7) Females with marked cystocele or other clinically significant Stage 3 or Stage 4 pelvic prolapse as defined by ICS 8) Intermittent urinary tract infections (UTIs) (3 or more UTIs per year over the preceding 2 years) or acute UTI at Visit 1. UTIs must be resolved prior to patient receiving screening diary at Visit 2. 9) History of chronic pain syndrome of the lower urinary tract, such as interstitial cystitis and pelvic pain 10)Any history of carcinoma of the lower urinary tract 11)History of any carcinoma within the last 5 years 12)Patients with uninvestigated hematuria 13)Any urogenital surgery (including thermotherapy/ultrasound/laser therapy of the prostate, prostatectomy, hysterectomy, incontinence surgery, etc.) within 12 months prior to Visit 1; bladder or prostate biopsy 30 days prior to Visit 1; instrumentation of the lower urinary tract (including cystoscopy, urodynamics) within 14 days prior to Visit 1 14)Any history of pelvic radiation therapy 15)Indwelling catheter or intermittent self-catheterization 16)Participation in a bladder-training program or any electro stimulation therapy within 3 months prior to Visit 1 or at any time during the study 17)Chronic persistent local pathology that in the opinion of the investigator may lead to urinary symptoms, e.g. fecal impaction and severe constipation (by the Rome II Criteria definition as 2 or less bowel movements per week accompanied by all, some or none of the following symptoms of straining, hard stool, abdominal fullness and incomplete evacuation) 18)Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow- angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon 19)Having received the following medications: • Potent inhibitors of cytochrome CYP3A4 (e.g., protease inhibitors, ketoconazole and itraconazole) or potent P-glycoprotein inhibitors such as cyclosporine and verapamil taken within 4 weeks prior to Visit 2 • Cholinergic agonists, e.g., bethanecol taken within two weeks prior to Visit 2 • Unstable dose in the last three months of drugs with significant anticholinergic effects such as SSRI's (e.g.paroxetine), tricyclic antidepressants (e.g. imipramine), and first generation antihistamines. However, trazadone is permitted • Unstable dose in the last three months of opioids or other drugs that cause significant constipation 20)Curren
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d. at week 2) versus placebo with respect to the change from baseline in the number of urge urinary incontinence episodes (UUIE) per week at week 12 in patients = 65 years with OAB.;Secondary Objective: A) Efficacy: Evaluate the efficacy of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d. at week 2) versus placebo with respect to change from baseline. All these parameters are evaluated at defined intervals during the week: • Number of UUIE per week, number of micturitions per day, number of urgency episodes per day, number of urinary incontinence pads used per week, and the number of nocturnal voids due to OAB per week. B) Safety: • Assess the safety and tolerability of darifenacin (7.5 mg o.d. with voluntary up- titration to 15 mg o.d. at week 2) C) Quality of Life & perception of outcome: • Patients quality of life using OAB-questionnaire, satisfaction with treatment using OAB-SAT-questionnaire, perception of outcome using PPBC questionnaire, treatment benefit using patient’s and physician’s assessment and previous treatment assessment using PPTA questionnaire at defined intervals. ;Primary end point(s): To evaluate the efficacy of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d. at week 2) versus placebo with respect to the change from baseline in the number of urge urinary incontinence episodes (UUIE) per week at week 12 in patients = 65 years with OAB. | — |
Countries
Germany, Hungary, Sweden, United Kingdom
Outcome results
None listed