A 12-week, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety and tolerability of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d.) in patients aged = 65 years with overactive bladder - Not applicable

• Register: EUCTR
• Last refreshed on: 2 February 2015
• Main ID: EUCTR2004-002894-21-GB
• Date of registration: 16/03/2005
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A 12-week, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety and tolerability of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d.) in patients aged = 65 years with overactive bladder - Not applicable
• Scientific title: A 12-week, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety and tolerability of darifenacin (7.5 mg o.d. with voluntary up-titration to 15 mg o.d.) in patients aged = 65 years with overactive bladder - Not applicable
• Date of first enrolment: 21/06/2005
• Target sample size: 399
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002894-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Hungary, Sweden, United Kingdom

Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Overactive bladder (OAB)

Intervention(s)

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 tablet
Route of administration of the placebo: Oral use

Trade Name: EMSELEX 15 prolonged-release tablets
Product Name: EMSELEX 15 mg
Product Code: DAR328A
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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.

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.

Secondary ID(s)

CDAR328A2409