Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-005295-33
    Sponsor's Protocol Code Number:S54913
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-005295-33
    A.3Full title of the trial
    Monocentric, open-label, phase III study that compares the efficiency and tolerance between intravesical oxybutynin and oral fesoterodine in children (5-16y) with neurogenic detrusor overactivity.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study compares intravesical oxybutynin and oral fesoteridine in children with a neurogenic overactive bladder. Both antimuscarinics lower the activity of the overactive bladder and by consequence lower the pressure in the bladder, what is important to protect the higher urinary tract system. Fesoterodine works more bladderspecific, that's why it's better tolerated than oxybutynin. 1 pill of fesoterodine a day would be more practical to use than 2 bladderinstillations of oxybutynin a day.
    A.4.1Sponsor's protocol code numberS54913
    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 SponsorUZ Leuven-Department of Urology
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUZ Leuven-Department of Urology
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven-Department of Urology
    B.5.2Functional name of contact pointGuy Bogaert
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 30
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3216346930
    B.5.5Fax number+3216346931
    B.5.6E-mailguy.bogaert@uzleuven.be
    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
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNfesoterodinefumaraat
    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 typeup to
    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) 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameOxybutynine.HCl 5mg/5ml
    D.3.2Product code 110073
    D.3.4Pharmaceutical form Intravesical solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxybutynine.HCl 5mg/5ml
    D.3.9.1CAS number 1508-65-2
    D.3.9.3Other descriptive nameOXYBUTYNIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Detrusitol retard
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNTOLTERODINE
    D.3.9.1CAS number 124937-51-5
    D.3.9.4EV Substance CodeSUB11180MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 4
    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
    children with neurogenic detrusor overactivity
    E.1.1.1Medical condition in easily understood language
    Children (5-16y) who have an overactive bladder which causes high pressure in the bladder what could damage the higher urinary tract system.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041524
    E.1.2Term Spina bifida
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficiency and tolerance of fesoterodine in comparison with intravesical oxybutynin +/- tolterodine in children with neurogenic detrusor overactivity.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - the study population consists of 20 patients
    - age: 5-16y
    - bodyweight: >20kg
    - stable neurogenic detrusor overactivity prooved with urodynamic investigation
    - all of them need intermittent catheterisation
    - the study patients take already oxybutynin+/-tolterodine
    - they will be all informed and one of the parents need to sign an informed consent when they agree with the participation of their child
    E.4Principal exclusion criteria
    - high sensibility for fesoterodin, tolterodin or oxybutinin
    - pinda/soya allergy
    - galactose-intolerance, lactase-deficiency, glucose-galactose-malabsorption
    - pathologies/surgeries that can disturb the absorption of fesoterodine: gastrectomy, stomach-retention, hypoperistalsis, myasthenia gravis, intestinal obstruction, severe colitis ulcerosa, toxic megacolon
    - surgeries who raise the risk of fesoterodine or who interact with the study results eg urinary sfincterotomy, artificial urinary sfincter, bladder augmentation
    - comorbidities who raise the risk of fesoterodine or who interact with the study results eg bladderlithiasis, closed-angle glaucoma, severe liver dysfunction(child pugh C)
    - autonomic dysreflexia
    - autonomic neuropathy
    - transurethral catheterization for 4 weeks prior to the study
    - relevant abnormal laboratory parameters(hematology, biochemic)
    - relevant abnormal heart frequency or an irregular heartbeat
    - medication who can interact with fesoterodine: CYP3A4-inductors or strong CYP3A4-inhibitors for 3 weeks prior to/during the study or the possibility that they need to start this type of medication during the study
    - botox treatment 9 months prior to the study
    - antispasmodic, parasympatomimetic, cholinergic medication during the study
    - intermittent or unstable use of diuretics, alfa-blockers, tricyclic antidepressants, neuroleptica
    - use of other experimental medication 4 weeks prior to the study
    - electrostimulation therapy that was started during the month prior to the study
    - pregnancy
    - family members of the investigators of the study

    take caution when there is:
    - mild liver dysfunction
    - kidney dysfunction
    - higher risk at long QT(low potassium, bradycardy, medication that prolong QT)
    E.5 End points
    E.5.1Primary end point(s)
    maximum cystometric bladder capacity=
    maximal tolerable cystometric capacity
    - until voiding
    - until leaking
    - at 40 cmH2O
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 1 and 7, before and after admission of fesoterodine
    E.5.2Secondary end point(s)
    urodynamic investigation:
    - detrusor pressure at maximal bladder capacity
    - bladder volume at first involuntary detrusor contraction(IDC)(= detrusor pressure higher than 10cmH2O)

    miction diary:
    - mean number of catheterizations/24hrs
    - mean volume per catheterization
    - mean number of incontinence episodes/24hrs

    Anamnestic:
    - most frequent complications of anticholinergics:
    dry mouth, dry eyes, constipation, nausea, hyperthermia, behavioral changes, decreased cognitive function, headache, seizures, somnolence, accommodation disorder, blurred vision, amblyopia

    Urinalysis: urinary tract infection

    Vital signs: body temperature, heart rate, tension

    Clinical laboratory evaluations: liver function, kidney function, hematology, biochemics

    Pregnancy test when there is a possibility

    Post-void residual volume when there is more than 1 urinary tract infection during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    history, medication, vital signs, clinical examination,blood, pregnancytest,urinanalysis:DAY14 until -1

    mictiondiary I:3 DAYS before WEEK 1

    urodynamics, child behavior checklist, snellen test, push up test: WEEK 1

    miction diary II: WEEK 2 day 4-7, the period that they stop their current anticholinergics (oxy bladder instillations+/- tolt)

    WEEK 3: stop oxy and tolt, start feso 25kg-40kg 4mg/day, >40kg 8mg/day, inform how the first intake went

    WEEK 4: complications?

    WEEK 6: complications?

    miction diary III:3 DAYS before WEEK 8

    WEEK 8:urodynamics, complications?, vital signs, clinical examination, blood, urinanalysis, child behavior checklist, snellen test, push up test
    STOP feso,restart oxy+/- tolt

    WEEK 10:late complications?preference of the patient?
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 20
    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: 10
    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 Yes
    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
    age 5-16y, some of them are too young or mentally retardated, so one of the parents has to sign the informed consent, to confirm that they agree that their child will participate.
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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)
    At week 8, right after the 2nd urodynamic investigation, they stop fesoterodine and restart their anticholinergics as before the study. 2 weeks after stop of fesoterodine, we will call them to see if there are any late complications. After that telephone visit the trial is closed.
    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 Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-21
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 18 23:57:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA