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    The EU Clinical Trials Register currently displays   36119   clinical trials with a EudraCT protocol, of which   5940   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-002094-55
    Sponsor's Protocol Code Number:1861
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-08-14
    Trial 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 number2019-002094-55
    A.3Full title of the trial
    Safety and feasibility of S-Caine patch use in children under the age of three
    Veiligheid en haalbaarheid van S-Caine patch gebruik bij kinderen onder de leeftijd van drie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety and feasibleness of a medical patch containing products to diminish the perception of pain in the skin, in children younger than three.
    A.3.2Name or abbreviated title of the trial where available
    S-Caine patch study
    A.4.1Sponsor's protocol code number1861
    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 SponsorUniversitair Ziekenhuis Brussel, Belgium
    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 supportUniversitair Ziekenhuis Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Brussel, Belgium
    B.5.2Functional name of contact pointCentraal Studieloket Clinical Trial
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3224775657
    B.5.6E-mailCentraal_Studieloket@uzbrussel.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 Rapydan patch (medicated plaster)
    D.2.1.1.2Name of the Marketing Authorisation holderEurocept International BV (NL)
    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.3.1Product nameRapydan
    D.3.2Product code SE/H/0762/001
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    children under the age of three that are in possession of a central catheter and under permanent monitoring (healthy, or any condition)
    E.1.1.1Medical condition in easily understood language
    children under the age of three that are in possession of a central catheter (in order to take blood samples) and under permanent medical supervision by a monitor and professionals
    E.1.1.2Therapeutic area Health Care [N] - Health Care Economics and Organizations [N03]
    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
    The objectives of this study are to evaluate safety and feasibility of the use of S-Caine Patch in children younger than three years old, by (1) determining plasma levels of lidocaine following skin application of one S-Caine Patch; (2) monitoring local and systemic possible adverse events after application of one S-Caine Patch
    E.2.2Secondary objectives of the trial
    evaluating the ease of use of applying a S-Caine Patch in children younger than three
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting the following criteria were eligible for inclusion in the study: all patients who were
    - children up to the age of three
    - admitted to the hospital and monitored
    - judged by a physician to have stable vital signs
    - in possession of a peripheral or central venous or arterial catheter allowing blood sampling
    - granting written informed consent, signed and dated by a legal guardian of the subject
    E.4Principal exclusion criteria
    Subjects were to be excluded from study participation based on any of the following criteria: patients who:
    - were older than three
    - were not admitted
    - were in absence of a catheter allowing unrestricted blood sampling
    - showed life threatening pathology (respiratory, circulatory or neurological impairment or instability) or needed a warming blanket in the 24 hours prior to inclusion
    - had metabolic, liver or kidney diseases, were prematurely born (gestational age < 37 weeks), or suffered from bronchopulmonary dysplasia
    - suffered from methaemoglobinaemia
    - suffered from anaemia defined as either plasma haemoglobin levels < 11g/dL and/or haematocrit levels of below 30%.
    - suffered from skin diseases preventing the use of patches (hypersensitive skin, atopic dermatitis, damaged, denuded or broken skin at the designated patch site,…)
    - suffered from known allergy or sensitivity to lidocaine and/or tetracaine or other local anaesthetics of the amide or ester type
    - suffered from known sensitivity to one of the components of the S-Caine Patch (e.g. sulphites, adhesives, …)
    - received products containing lidocaine, and/or tetracaine within 24 hours before inclusion
    - patients with history of the use of cocaine, or other drugs that might cause an additive pharmacological affect with either lidocaine and/or tetracaine. Subjects younger than 2 years old or still receiving breast feeding would be excluded if the mother had a history of cocaine use.
    - did not have parents sign informed consent
    - were withdrawn by their parents
    E.5 End points
    E.5.1Primary end point(s)
    Analyse plasma lidocaine levels in order to determine if they stay within safe limits for children under the age of three; monitor possible (new) adverse effects (local and systemic) of the use of the S-Caine patch in children younger than three
    E.5.1.1Timepoint(s) of evaluation of this end point
    time (min): 0-15-30-60-120- (later)
    E.5.2Secondary end point(s)
    evaluate the ease of use of the existing S-Caine patch in children younger than three
    E.5.2.1Timepoint(s) of evaluation of this end point
    time (min): 0-15-30-60-120- (later)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    each patient is its own control
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    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 years2
    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: 100
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 33
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 33
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 34
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    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 under the age of three
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    Patients will not need further care different than standard practice for their eventual condition (separated from this study), but can always contact investigators/hospital/ED/ dpo/etc…, as stipulated in the informed consent forms handed over to the child's caregiver.
    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 Decision2019-09-09
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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