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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-006070-22
    Sponsor's Protocol Code Number:A0221007
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-31
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-006070-22
    A.3Full title of the trial
    A 12-WEEK, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE EFFECTS OF FESOTERODINE ON TREATMENT SATISFACTION AND SYMPTOM RELIEF IN OVERACTIVE BLADDER PATIENTS
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberA0221007
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Applicable
    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 Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 No
    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.3.2Product code PF-00695838
    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.3.9.1CAS number 286930-03-8
    D.3.9.2Current sponsor codePF-00695838
    D.3.9.3Other descriptive nameFesoterodine
    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 No
    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.3.2Product code PF-00695838
    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.3.9.1CAS number 286930-03-8
    D.3.9.2Current sponsor codePF-00695838
    D.3.9.3Other descriptive nameFesoterodine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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
    Overactive bladder (OAB) is a symptom complex defined by the International
    Continence Society (ICS) as the symptoms of urgency, with or without urgency
    incontinence, usually with frequency and nocturia. While incontinence is often considered the most bothersome symptom of OAB, urgency and increased urinary frequency also severely impair the quality of life of patients and reduce their well-being and social contacts.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder
    (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy
    with tolterodine.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effects of fesoterodine on quality of life (QoL) and secondary
    micturition diary endpoints in OAB patients who were dissatisfied with their prior
    therapy with tolterodine.
    2. To evaluate tolerability and safety of fesoterodine in OAB patients who were
    dissatisfied with their prior therapy with tolterodine.
    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 enrollment 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. Previously treated (within 2 years prior to Screening) or being treated with tolterodine or tolterodine ER for OAB.
    4. Reported being “somewhat dissatisfied” or “very dissatisfied” with their prior
    treatment with tolterodine or tolterodine ER on the prior Treatment Satisfaction
    Question (pTSQ) at Screening/ Visit 1.
    5. Mean urinary frequency of ≥ 8 micturitions per 24 hours as verified by the screening micturition diary prior to Baseline/Visit 2.
    6. 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).
    7. Rate their bladder condition as “Some Moderate Problems”, “Severe Problems”, or
    “Many Severe Problems” on the Patient Perception of Bladder Condition (PPBC)
    questionnaire at Baseline/Visit 2.
    8. Able and willing to complete the micturition diaries and all trial related
    questionnaires, comply with scheduled clinic visits and clinical trial procedures.
    9. 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.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Any condition that would contraindicate their usage of fesoterodine, including:
    • Hypersensitivity to the active substance (fesoterodine) 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
    • toxic megacolon.
    2. Documented significant hepatic or renal disease, defined as twice the upper limit of
    the reference ranges for serum concentrations of AST, ALT, ALP, urea nitrogen, or
    creatinine.
    3. Neurologic conditions, such as stroke, multiple sclerosis, spinal cord injury, or
    Parkinson’s disease.
    4. Stage 3 or greater 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 surgery (e.g. incontinence surgery or surgery to reduce prostate size) 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. 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. Have started any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Visit 1.
    12. Previously treated with 3 or more antimuscarinic OAB medications within 12 months prior to screening [Note: any current treatment must stop at screening]; the
    antimuscarinic OAB medication may include:
    • darifenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium
    13. Expectation of initiating treatment during the study 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 throughout study duration. Treatment with diuretics initiated within 2 weeks prior to baseline is not permitted.
    15. Treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics
    (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungal
    agents (i.e., ketoconazole, itraconazole), protease inhibitors, or the expectation to start such a treatment during the trial.
    16. Administration of medications capable of inducing hepatic enzyme metabolism or
    transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St.
    John’s Wort) in the past 30 days.
    17. Previously received any investigational drug within 30 days prior to study entry.
    18. Previously participated in any fesoterodine clinical trial.
    19. Alcohol and/or any other drug abuse in the opinion of the investigator.
    20. Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study.
    21. Female subjects of childbearing potential who are heterosexually active but not using an adequate form of contraception. Reliable contraceptive methods defined as
    intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide.
    22. Subjects who have any medical (including known history of major hematological,
    renal, cardiovascular, or hepatic abnormalities) or psychological condition or social
    circumstances that would impair their ability to participate reliably in the study, or
    those who may increase the risk to themselves or others by participating.
    23. Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of subjects reporting satisfaction (including ‘very satisfied’ and
    ‘somewhat satisfied’) with their current OAB treatment using the Treatment Satisfaction Question at Week 12
    • Change in mean number of micturition episodes per 24 hours at week 12 relative to
    baseline.
    • Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at week 12 relative to the baseline in subjects with a baseline of UUI ≥ 1 episode(s) during the 5-day urinary diary period.
    • Change in mean number of urgency episodes per 24 hours at week 12 relative to
    baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating
    of ≥ 3 in the diary).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    satisfaction of patient
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Possible increased dose in 2nd phase dependent on patient satisfaction/response to therapy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of Trial in a Member State of the European Union is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial as stated in the regulatory application and ethics application in the Member State.
    End of Trial in all participating countries is defined as Last Subject Last Visit.
    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 months11
    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 months11
    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 No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 400
    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 Decision2007-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-11
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