A 24-WEEK, MULTICENTRE TRIAL, COMPRISING A 12-WEEK, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE FOLLOWED BY A 12-WEEK OPEN-LABEL PHASE, TO EVALUATE THE EFFICACY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2007-007087-17-GB
• Date of registration: 26/03/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK
• Public title: A 24-WEEK, MULTICENTRE TRIAL, COMPRISING A 12-WEEK, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE FOLLOWED BY A 12-WEEK OPEN-LABEL PHASE, TO EVALUATE THE EFFICACY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER
• Scientific title: A 24-WEEK, MULTICENTRE TRIAL, COMPRISING A 12-WEEK, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE FOLLOWED BY A 12-WEEK OPEN-LABEL PHASE, TO EVALUATE THE EFFICACY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER
• Date of first enrolment: 12/11/2008
• Target sample size: 790
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007087-17
• 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: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, Denmark, Finland, Germany, Italy, Portugal, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female outpatients =65 years old.
2. Overactive bladder symptoms (subject-reported) for =3 months prior to Screening/Enrolment visit (Visit 1) according to ICS guidelines.
3. Mean urinary frequency of =8 micturitions per 24 hours as verified by the micturition diary prior to Randomization/Baseline visit (Visit 2).
4. Mean number of Urgency episodes =3 per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2 (Urgency episodes are defined as those with Bladder Sensation Scale rating =3).
5. Rate their bladder as causing “Some Moderate Problems”, “Severe Problems”, or “Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC) questionnaire at Baseline/Visit 2.
6. Able and willing to complete the micturition diaries and all trial related questionnaires and comply with scheduled clinic visits and clinical trial procedures.
7. Mini-Mental State Examination Score of =20.
8. 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.
9. All women who are enrolled into this study must be post menopausal as assessed by the investigator.

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. Predominant Stress Incontinence. Stress urinary incontinence as determined/estimated by the investigator.
3. Stage 3 or greater pelvic organ prolapse defined as tissue visible through introitus in lithotomy position at rest (without increase in intra abdominal pressure).
4. Transurethral resection of the prostate (TURP) or bladder (TURB)) and other minor surgery (eg, cystoscopic procedures) performed within the past 6 months or history of any major lower urinary tract surgery (eg, incontinence surgery or radical prostatectomy) at any time.
5. 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, clinical suspicion of prostate carcinoma, known mullerian duct cysts, radiation cystitis, or genito-urinary tuberculosis.
6. Active bladder stones. Patients with a previous history of bladder stones may be included.
7. Previous history of acute urinary retention requiring catheterisation, clinically significant bladder outflow obstruction or severe voiding difficulties in the judgment of the investigator.
8. Use of an indwelling catheter or an intermittent self-catheterization program.
9. Active 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. Subjects with a UTI detected at screening may be treated (while remaining on study as part of an extended screening period) and retested 2 weeks after the subject has finished treatment.
10. Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Visit 2.
11. Multiple sclerosis or spinal cord injury.
12. Treatment with antimuscarinic OAB medication within 2 weeks prior to Visit 2, including any preparation containing:
• darifenacin, oxybutynin, propiverine, tolterodine and trospium.
13. Treatment with solifenacin within 3 weeks prior to Visit 2.
14. Intermittent or unstable use of diuretics or alpha blockers, or initiation of such treatment(s) within 2 weeks prior to Visit 2.
15. Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Visit 2.
16. Participated in any clinical trial or received any investigational drug within 4 weeks prior to Visit 2.
17. Has any current malignancy except:
a. Those >5 years ago without recurrence.
b. Excised basal cell carcinoma or squamous cell carcinoma of skin.
18. Other severe or acute medical condition (including newly diagnosed diabetes mellitus or newly diagnosed hypertension requiring treatment, or major hematological or cardiovascular conditions) or psychological condition or social circumstances that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of the study results or may impair ability to participate reliably in the trial, or may increase the risk to themselves or

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 (Some patients will also have urgency urinary incontinence (UUI)).
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

Primary Outcome(s)

Secondary Objective: • To compare the effect of 12-week, flexible dose regimens of Fesoterodine relative to placebo on other patient reported outcomes in elderly subjects with OAB.
• To assess the safety and tolerability of 12-week, flexible dose regimens of Fesoterodine relative to placebo in elderly subjects with OAB.
• To assess the safety, tolerability and efficacy of an open label flexible dose regimen of Fesoterodine in elderly subjects with OAB for a further 12 weeks of treatment following the double blind placebo controlled phase.
• To compare the efficacy and tolerability of morning versus evening dosing of Fesoterodine SR

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).

Main Objective: To compare the efficacy, in terms of a reduction of urgency episodes, of 12-weeks flexible dose Fesoterodine relative to placebo in elderly subjects with OAB.

Secondary ID(s)

A0221045

2007-007087-17-SE