A 12 week, multicentre, open label study to evaluate the efficacy, tolerability and safety of a Fesoterodine flexible dose regimen in patients with overactive bladder

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-004124-23-GB
• Date of registration: 20/01/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited
• Public title: A 12 week, multicentre, open label study to evaluate the efficacy, tolerability and safety of a Fesoterodine flexible dose regimen in patients with overactive bladder
• Scientific title: A 12 week, multicentre, open label study to evaluate the efficacy, tolerability and safety of a Fesoterodine flexible dose regimen in patients with overactive bladder
• Date of first enrolment: 29/01/2009
• Target sample size: 326
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004124-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
1. Male or female outpatients =18 years old.
2. Overactive bladder symptoms (subject-reported) for =3 months prior to Screening/Visit 1.
3. Mean urinary frequency of ?=8 micturitions per 24 hours as verified by the screening bladder diary prior to Baseline/Visit 2.
4. Mean number of Urgency episodes =3 per 24 hours as verified by the screening bladder diary prior to Baseline/Visit 2 (Urgency episodes are defined as those with Urinary 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 Visit 2.
6. Able and willing to complete the micturition bladder diaries and all trial related
questionnaires, comply with scheduled clinic visits and clinical trial procedures.
7. Capability of understanding and having signed the informed consent form after full
discussion 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 the usage of fesoterodine including, but not limited to: hypersensitivity to the active substance (fesoterodine fumarate) or any of the excipients, or to peanut or soya; urinary retention; gastric retention; uncontrolled narrow angle glaucoma; myasthenia gravis; moderate or severe hepatic impairment (Child Pugh C); severe renal impairment; severe ulcerative colitis, and toxic megacolon.
2.Neurologic conditions, such as stroke, multiple sclerosis, spinal cord injury, or Parkinson’s disease.
3.Stage 3 or greater pelvic organ prolapse, defined as tissue protruding to or beyond the introitus in lithotomy position at rest (without increase in intra abdominal pressure).
4.History of lower urinary tract surgery (eg, incontinence surgery or surgery to reduce prostate size; or transurethral resection of the prostate (TURP) or bladder (TURBT) with the exception of any minor surgery (eg, cystoscopic procedures)) within the past 6 months.
5.A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated haematuria, 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 tumour, radiation cystitis, genito-urinary tuberculosis, bladder calculi, or detrusor-sphincter dyssynergia.
6.Active bladder stones. Subjects with a previous history of bladder stones may be included.
7.Previous history of acute urinary retention requiring catheterization, clinically relevant bladder outlet obstruction or severe voiding difficulties in the judgment of the investigator, prior to Visit 2.
8.Use of an indwelling catheter or an intermittent self-catheterisation programme.
9.Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
10.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.
11.Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks prior to Visit 1.
12.Treatment with antimuscarinic OAB medication within 3 weeks prior to Visit 2, including any preparation containing:
•Darifenacin, oxybutynin, propiverine, tolterodine, fesoterodine, solifenacin and trospium.
13.Initiation of treatment during the 16 week trial period with:
•Any drug treatment for overactive bladder.
•Any drugs with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects.
14.Intermittent or unstable use of diuretics or alpha blockers, or tricyclic antidepressants, oestrogen therapy and any 5AR inhibitors or initiation of such treatment(s) within 2 weeks prior to Visit 2.
15.Treatment with moderate or potent CYP3A4 inhibitors, such as grapefruit juice, macrolide antibiotics (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal agents (ie, ketoconazole, itraconazole), protease inhibitors within 3 weeks prior to Visit 2
16.Administration of medications capable of inducing hepatic enzyme metabolism or transport (eg, barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John’s Wort).
17.Participated in any clinical trial or received any inv

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

Health Condition(s) or Problem(s) studied

Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.
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 funarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Toviaz
Product Name: Fesoterodine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterdine
CAS Number: 286930-03-8
Other descriptive name: Fesoterodine funarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-

Primary Outcome(s)

Primary end point(s): Change in mean number of micturitions per 24 hours at Week 12 relative to baseline.

Main Objective: The primary objective is to demonstrate the efficacy, in terms of reduction of icturations, of 12 weeks flexible dose fesoterodine in subjects with OAB compared to baseline.

Secondary Objective: To assess the use of flexible dosing of fesoterodine on other bladder diary variables after 4 and 12 weeks compared to baseline.

To assess the effect of flexible dose fesoterodine on treatment satisfaction and health-related quality of life measures at 12 weeks compared to baseline.

To assess the safety and tolerability of flexible dose fesoterodine in subjects with OAB.

Secondary ID(s)

A0221058