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    Summary
    EudraCT Number:2014-004161-24
    Sponsor's Protocol Code Number:A0221066
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-24
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004161-24
    A.3Full title of the trial
    An Open-Label, Dose-Escalating Study of the Pharmacokinetics, Safety and Tolerability of Fesoterodine in Pediatric Overactive Bladder Patients Aged 8-17 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Of Fesoterodine In Pediatric patients with Overactive Bladder, Ages 8-17 Years
    A.4.1Sponsor's protocol code numberA0221066
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00857896
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd St
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001212733-2094
    B.5.5Fax number001212309-4209
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    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 Ltd
    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 fumarate prolonged release tablets; Toviaz
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    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 fumarate
    D.3.9.1CAS number 286930-03-8
    D.3.9.3Other descriptive nameFESOTERODINE
    D.3.9.4EV Substance CodeSUB25383
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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) and Neurogenic Detrusor Over activity
    E.1.1.1Medical condition in easily understood language
    Treatment of urinary bladder with symptoms of frequency, urgency, and urgency incontinence
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the pharmacokinetics of 5-hydroxy-methyltolterodine (5- HMT) in pediatric OAB subjects aged 8-17 years.
    E.2.2Secondary objectives of the trial
    To examine the influence of subject covariates on the pharmacokinetics of 5-HMT.
    To assess the safety and tolerability of fesoterodine in pediatric OAB subjects aged 8-17 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects between the ages of 8 and 17 years (age at time of first dose), inclusive.
    2. A total body weight greater than 25 kilogram (kg) or 55 pounds (lbs).
    3. Symptoms of urinary frequency (greater than or equal to [≥] 8 micturitions on average per 24 hours) and urgency (defined as a sudden and compelling desire to pass urine which is difficult to defer), with or without urgency incontinence, for at least 6 months prior to enrolment or subjects with stable neurological disease and urodynamically confirmed detrusor over activity, who may require intermittent catheterization for management of urinary drainage.
    4. Parents or legal guardians must give written informed consent prior to the start of the study. Consent should be obtained from both (if available) of the child’s legal representatives (parents or guardians). In addition, the child’s assent must be obtained.
    5. Female subjects must be non-pregnant and non-lactating, and, if applicable, be using an appropriate method of contraception for at least 28 days prior to the first dose of study medication and continue for at least 28 days after the final study drug dose. Subjects of child bearing potential must have confirmed negative urine pregnancy tests taken prior to randomization.
    6. Subjects and parents or legal guardians must be thought to be compliant and able to follow the investigator’s instructions. They must be able to visit the clinic on schedule and be both cooperative and reliable.
    E.4Principal exclusion criteria
    1. Subjects required to take concomitant medications that could have interacted with the pharmacokinetics (PK) and pharmacodynamics (PD) of fesoterodine, such as Cytochrome CYP3A4 inhibitors or inducers, CYP2D6 inhibitors, drugs for treatment of OAB, drugs with antispasmodic, parasympathetic, or cholinergic effects, drugs known to affect lower urinary tract function (eg, desmopressin).
    2. Subjects who had received any electro stimulation therapy or bladder retraining within 4 weeks of Visit 1 or who were expected to start such therapy during the study period.
    3. Subjects with monosymptomatic nocturnal enuresis, or giggle incontinence.
    4. Subjects with a clinically significant urinary tract infection at screening.
    5. Subjects with a relevant disease with which their urinary symptoms may have been associated like diabetes insipidus, untreated constipation, psychological disorders with impact on bladder function.
    6. Subjects with any condition that would have contraindicated or warranted precautions for the use of fesoterodine, including: hypersensitivity to fesoterodine or tolterodine, history of hypersensitivity to peanut or soya, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis and toxic megacolon.
    E.5 End points
    E.5.1Primary end point(s)
    Model-based pharmacokinetic parameter estimates for absorption rate constant, apparent oral clearance and volumes of distribution to predict the area under the plasma drug concentration versus time curve (AUC), maximum concentration (C max), time to reach maximum concentration (T max) and half-life of 5-HMT in pediatric OAB subjects aged 11-17 years.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28, Day 56
    E.5.2Secondary end point(s)
    Laboratory tests, post-void residual volume in subjects who are not performing clean intermittent bladder catheterization (CIC) and adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 4, Week 8 post-dose
    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 Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 21
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 11
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents aged 8 to 17 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 21
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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