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    Summary
    EudraCT Number:2014-001751-23
    Sponsor's Protocol Code Number:6/13
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2014-08-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001751-23
    A.3Full title of the trial
    Comparative evaluation of the effectiveness of EMLA vs. Ralydan in the procedures for venipuncture and venous cannulation. Randomized controlled trial..
    Valutazione comparativa dell'efficacia di Ralydan vs EMLA nelle procedure di venipuntura e incannulamento venoso. Trial controllato randomizzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ralydan vs EMLA in venous punture and incannulation procedure
    Ralydan VS EMLA nella procedura di iniezione endovenosa e incannulamento
    A.3.2Name or abbreviated title of the trial where available
    Ralydan vs EMLA
    Ralydan VS EMLA
    A.4.1Sponsor's protocol code number6/13
    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 SponsorIRCCS Burlo Garofolo
    B.1.3.4CountryItaly
    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 supportIRCCS Burlo Garofolo
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Burlo Garofolo
    B.5.2Functional name of contact pointAlessandra Maestro
    B.5.3 Address:
    B.5.3.1Street AddressVia dell'Istria 65/1
    B.5.3.2Town/ cityTrieste
    B.5.3.3Post code34137
    B.5.3.4CountryItaly
    B.5.4Telephone number00390403785417
    B.5.5Fax number00390403785411
    B.5.6E-mailalessandra.maestro@burlo.trieste.it
    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 Ralydan 70 Mg/70 Mg
    D.2.1.1.2Name of the Marketing Authorisation holderEurocept International B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameRalydan 70 Mg/70 Mg
    D.3.4Pharmaceutical form Transdermal patch
    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.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 Yes
    D.2.1.1.1Trade name EMLA 2,5% + 2,5%
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameEMLA 2,5% + 2,5%
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Procedures for venipuncture and venous incannulation in pediatric patients
    Procedure di venipuntura e incannulamento venoso in pazienti pediatrici
    E.1.1.1Medical condition in easily understood language
    Venipuncture through butterfly needles and needle-cannulas for infusion
    Esecuzione di prelievo venoso attraverso aghi a farfalla e ago-cannule per infusione
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10059445
    E.1.2Term Venipuncture
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the efficacy of EMLA vs. Ralydan in procedures for venipuncture or venous incannulation when the two devices have achieved the effect of anesthetic (EMLA for 60 min and 30 min for Ralydan).
    Confrontare l’efficacia di EMLA vs Ralydan sul successo delle procedure di venipuntura o incannulamento venoso quando i due dispositivi hanno raggiunto l’effetto anestetico (60 min per EMLA e 30 min per Ralydan).
    E.2.2Secondary objectives of the trial
    Number of attempts needed to perform the procedure of venipuncture and incannulation
    Numero di tentativi necessari ad eseguire la procedura di venipuntura ed incannulamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children aged 3 to 10 years
    - The need to perform venipuncture or venous incannulation.
    - età compresa tra 3 e 10 anni
    - necessità di eseguire un prelievo o un incannulamento venoso.


    E.4Principal exclusion criteria
    - Subjects who need urgent care
    - Subjects with known hypersensitivity to local anesthetics
    - Subjects enrolled in other studies for venipuncture / cannulation
    - soggetti che necessitano di cure urgenti
    - soggetti con ipersensibilità nota agli anestetici locali in studio
    - soggetti arruolati in altri studi per prelievo venoso/incannulamento
    E.5 End points
    E.5.1Primary end point(s)
    Success of the procedure at first attempt in relation to the anesthetic used (EMLA vs. Ralydan)
    Successo della procedura al primo tentativo in relazione all’anestetico utilizzato (EMLA vs Ralydan)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 or 60 minutes
    30 o 60 minuti
    E.5.2Secondary end point(s)
    1. The effectiveness of the two local anesthetics in reducing pain, assessed by administering VAS scale or Wong-Backer scale, depending on the age of the patient.
    2. Effectiveness of the two local anesthetics in reducing pain according to evaluation by the medical staff with the VAS scale.
    3. Number of attempts needed to carry out the procedure
    1. l’efficacia dei due anestetici locali nel ridurre il dolore, valutato mediante somministrazione di scale VAS o Wong-Backer, a seconda dell'età del paziente.
    2. l’efficacia dei due anestetici locali nel ridurre il dolore in base a valutazione realizzata dal personale sanitario con scala VAS.
    3. numero di tentativi necessari per realizzare la procedura
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 or 60 minutes
    30 o 60 minuti
    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 No
    E.6.5Efficacy No
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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
    Ultima visita dell'ultimo paziente
    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 months12
    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: 320
    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: 320
    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 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
    Pediatric patients
    Pazienti pediatrici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state320
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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)
    Pain assessment with different reference scales up to 5 minutes after the execution of the procedure
    Valutazione del dolore con diverse scale di riferimento fino a 5 minuti dopo l’esecuzione della procedura
    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 Decision2014-11-11
    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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