12-WEEK, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED, PARALLEL-GROUP, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE IN COMPARISON TO TOLTERODINE ER IN PATIENTS WITH OVERACTIVE BLADDER

• Register: EUCTR
• Last refreshed on: 16 October 2012
• Main ID: EUCTR2007-006451-39-LV
• Date of registration: 02/04/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: 12-WEEK, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED, PARALLEL-GROUP, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE IN COMPARISON TO TOLTERODINE ER IN PATIENTS WITH OVERACTIVE BLADDER
• Scientific title: 12-WEEK, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED, PARALLEL-GROUP, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE IN COMPARISON TO TOLTERODINE ER IN PATIENTS WITH OVERACTIVE BLADDER
• Date of first enrolment: 07/05/2008
• Target sample size: 1675
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006451-39
• 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: yes Other trial design description: Double-Dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Bulgaria, Estonia, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female outpatients =18 years old;
2. Overactive bladder symptoms (subject-reported) for =3 months prior to Screening/Enrollment visit (Visit 1);
3. Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder
diary prior to the Randomization/Baseline visit (Visit 2);
4. Mean urinary frequency of =8 micturitions per 24 hours as verified by the 3-day
bladder diary prior to Randomization/Baseline visit (Visit 2);
5. Able and willing to complete the bladder 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:
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, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal (ULN).
3. Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease, which are known or suspected of influencing the subject’s bladder function.
4. Significant 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/pelvic surgery (eg, surgery for incontinence, prolapse, or benign prostate hyperplasia, hysterectomy) 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, genito-urinary 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. Has polyuria (>3000mL/24h) or a voided volume >500mL for any micturition during the run-in 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, participation in a formal program of bladder training, or pelvic floor exercises under the supervision of a physician or other medical provider within 4 weeks of Visit 1.
13. Received study medication in any previous fesoterodine clinical trial.
14. Treated with the following drugs within 2 weeks prior to Visit 1:
• Any drug treatment for overactive bladder, including antimuscarinic OAB medications;
• Any drugs with significant anticholinergic and antispasmodic effects.
15. Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Visit 1 and/or is not on a stable dose.
16. Has started treatment with diuretics or alpha blockers within 2 weeks prior to Visit 1 and/or is not on a stable dose.
17. Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Visit 1.
18. Administration of medications capable of inducing hepatic enzyme metabolism or transport (eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort) in the past 30 days.
19. Previously received any investigational drug within 30 days prior to trial entry.
20. Alcohol and/or any other drug abuse in the opinion of the investigator.
21

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

Health Condition(s) or Problem(s) studied

Treatment of overactive bladder with symptoms of frequency, urgency, and urgency incontinence.
MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder

Intervention(s)

Trade Name: Toviaz
Product Name: Fesoterodine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterodine
CAS Number: 286930-03-8
Other descriptive name: Fesoterodine Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Toviaz
Product Name: fesoterodine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterodine
CAS Number: 286930-03-8
Other descriptive name: Fesoterodine Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Tolterodine
Pharmaceutical Form: Prolonged-release capsule, hard
CAS Number: 124937-52-6
Other descriptive name: PNU-200583E, Tolterodine Tartrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: • To compare the effect of fesoterodine with that of placebo on patient reported outcomes in subjects with overactive bladder, after 12 weeks of treatment
• To compare the efficacy of fesoterodine 4mg QD with that of placebo in subjects with overactive bladder, after 1 week of treatment
• To summarize safety data for 12 weeks of treatment with either fesoterodine,
tolterodine ER, or placebo in subjects with overactive bladder

Main Objective: To compare the efficacy of fesoterodine with that of placebo and of tolterodine ER in
subjects with overactive bladder, after 12 weeks of treatment.

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 micturitions
with Urinary Sensation Scale rating of 5 in the diary).

Secondary ID(s)

2007-006451-39-SE

A0221046