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    Summary
    EudraCT Number:2008-004124-23
    Sponsor's Protocol Code Number:A0221058
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2008-004124-23
    A.3Full title of the trial
    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
    A.4.1Sponsor's protocol code numberA0221058
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Toviaz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFesoterodine
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFesoterodine
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive nameFesoterodine funarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Toviaz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFesoterodine
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFesoterdine
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive nameFesoterodine funarate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of the symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 investigational drug within 4 weeks prior to Visit 2.
    18.Abuse of alcohol and/or any other drug in the opinion of the investigator.
    19.Female subjects who are pregnant, nursing, or who are intending to become pregnant during the trial or within 3 months after the completion of the trial.
    20.Female subjects of childbearing potential who are heterosexually active but not using an adequate form of contraception. Reliable contraceptive methods (need at least 2) defined as hormonal methods of contraception (including oral, patches, injected, implants, IUDs (intrauterine device)) at least 14 days prior to the first dose of trial medication; placement of a copper-containing intrauterine device (IUD) condom with spermicidal foam/gel/film/cream/suppository, tubal ligation male partner who has had a vasectomy for a least 4 months or abstinence.
    21.Any medical (including known history of major haematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating.
    22.Has any current malignancy except:
    •Those >5 years ago without recurrence.
    •Excised basal cell skin carcinoma or squamous cell cancer.
    23.Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean number of micturitions per 24 hours at Week 12 relative to baseline.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state326
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 326
    F.4.2.2In the whole clinical trial 326
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-14
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