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    Summary
    EudraCT Number:2015-003915-39
    Sponsor's Protocol Code Number:54811
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-003915-39
    A.3Full title of the trial
    A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults.
    Is xylocaine spray nuttig als lokale pijnstiller bij venapuncties? Een gerandomiseerd, dubbelblind, placebogecontroleerd onderzoek.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Provides lidocaine spray sufficient analgesia for intravenous cannulation.
    Is xylocaine spray een effectieve pijnstiller voor het prikken van een infuus.
    A.3.2Name or abbreviated title of the trial where available
    Cutaneous xylocaine spray versus placebo spray
    Cutaan gebruik van xylocaine spray versus placebo spray
    A.4.1Sponsor's protocol code number54811
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    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 nameXylocaine spray
    D.3.2Product code D04AB01
    D.3.4Pharmaceutical form Cutaneous spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXylocaine
    D.3.9.1CAS number 137-58-6
    D.3.9.3Other descriptive nameLIDOCAINE
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    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 placeboCutaneous spray
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The enrolled subjects will get an intravenous cannulation in both elbows. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in de other arm before placebo spray is placed, the control arm. The pain score during insertion of de cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation.
    Er worden bij de geïncludeerde personen in beide elleboogsplooien infusen ingebracht. Er zal aan de proefpersonen worden gevraagd om de pijnscore tijdens het inbrengen van het infuus te noteren, tevens wordt er gekeken naar het optreden van bijwerkingen, de succespercentage en moeilijkheidsgraad bij het prikken van een infuus.
    E.1.1.1Medical condition in easily understood language
    The enrolled subjects will get an intravenous cannulation in both elbows. The pain score during insertion of de cannulation en the incidence of adverse events will be noted.
    Er worden bij de geïncludeerde personen in beide elleboogsplooien infusen ingebracht. De pijnscore tijdens het inbrengen van het infuus en het optreden van bijwerkingen zal worden genoteerd.
    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
    Has xylocaine spray an analgesic effect during the insertion of an intravenous cannulation?
    Heeft xylocaine spray een analgetische werking tijdens het inbrengen van een infuus?
    E.2.2Secondary objectives of the trial
    Are there any side effects when using xylocaine spray? Does xylocaine spray affect the successful placement of an intravenous cannulation?
    Treden er bijwerkingen op bij het gebruik van xylocaine spray? Heeft xylocaine spray invloed op het succesvol plaatsen van een infuus?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults (aged 18 or older)
    Signing of the informed consent paper
    Volwassenen (>18 jaar)
    Ondertekening van het informed consent
    E.4Principal exclusion criteria
    Allergy for xylocaine
    Pregnancy or breast-feeding
    Peripheral neuropathy
    Analgesics in the last 24 hours
    Skin conditions (eczema, psoriasis, infection, or abrasions)
    Difficulties in verbal communication
    No intravenous access in both elbows possible (eg status after axillary dissection)
    Overgevoeligheid voor xylocaine
    Zwangerschap of het geven van borstvoeding
    Perifere neuropathie
    Inname van analgetica de afgelopen 24 uur
    Huidaandoening (eczeem, psoriasis, infectie of een schaafwond)
    Bij problemen in de verbale communicatie
    Geen intraveneuze toegang in beide ellebogen mogelijk (o.a. status na okselkliertoilet)
    E.5 End points
    E.5.1Primary end point(s)
    The pain score of the tested subjects during intravenous cannulation.
    De pijnscore van de proefpersoon tijdens het plaatsen van een infuus.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all subjects were enrolled and data processing has been completed.
    Wanneer alle proefpersonen zijn geincludeerd en de dataverwerkingen is afgerond.
    E.5.2Secondary end point(s)
    Complications or adverse reactions of xylocaine spray
    Influence of xylocaine spray in successfully placing an IV cannulation
    The degree of difficulty in successfully placing an IV cannulation
    Complicaties en/of bijwerkingen van xylocaine spray
    Invloed van xylocaine spray op het succesvol plaatsen van een infuus
    De moeilijkheidsgraad bij het prikken van een infuus
    E.5.2.1Timepoint(s) of evaluation of this end point
    When all subjects were enrolled and data processing has been completed.
    Wanneer alle proefpersonen zijn geincludeerd en de dataverwerkingen is afgerond.
    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 No
    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
    Adequate analgesia with xylocaine spray during intravenous cannulation
    Adequate pijnstilling bij het inbrengen van een infuus met xylocaine spray.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial17
    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
    When all subjects were enrolled, the data processing has been completed and the article is written.
    Wanneer alle proefpersonen zijn geincludeerd, de dataverwerkingen is afgerond en het artikel is geschreven.
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 17
    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 No
    F.3.3Specific vulnerable populations No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17
    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
    Nee
    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 Decision2016-02-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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