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    Summary
    EudraCT Number:2010-021406-38
    Sponsor's Protocol Code Number:Finaledition
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-20
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-021406-38
    A.3Full title of the trial
    EMLA CREAM AS PAIN RELIEF DURING PNEUMOCOCCAL VACCINATION
    EMLA KRÄM SOM SMÄRTLINDRING VID PNEUMOKOCKVACCINATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMLA CREAM AS PAIN RELIEF DURING PNEUMOCOCCAL VACCINATION
    EMLA KRÄM SOM SMÄRTLINDRING VID PNEUMOKOCKVACCINATION
    A.3.2Name or abbreviated title of the trial where available
    EMLA CREAM AS PAIN RELIEF DURING PNEUMOCOCCAL VACCINATION
    EMLA KRÄM SOM SMÄRTLINDRING VID PNEUMOKOCKVACCINATION
    A.4.1Sponsor's protocol code numberFinaledition
    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 SponsorMariefreds Vårdcentral
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMariefreds Vårdcentral
    B.5.2Functional name of contact pointMariefreds Vårdcentral
    B.5.3 Address:
    B.5.3.1Street AddressSolvändan 3
    B.5.3.2Town/ cityMariefred
    B.5.3.3Post code647 23
    B.5.3.4CountrySweden
    B.5.4Telephone number+4615929012
    B.5.5Fax number+4615913255
    B.5.6E-mailbeatrice.olssonduse@dll.se
    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 Emla cream
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine and Prilocaine
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain relief with Emla cream during Pneumococcal vaccination.
    Kommer smärtlindring (Emla kräm) minska barnens smärtupplevelse vid första pneumokockvaccinationen (Prevenar 13) vid 3 månaders ålder inom barnhälsovården.
    E.1.1.1Medical condition in easily understood language
    Pain relief with Emla cream during Pneumococcal vaccination.
    Kommer smärtlindring minska barnens smärtupplevelse vid första pneumokockvaccinationen vid 3 månaders ålder inom barnhälsovården.
    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 aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care.

    Primary objective
    1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of FLACC as a pain measurement instrument?

    Syftet med denna interventionsstudie är att jämföra effekten av Emla kräm som smärtlindring eller ingen smärtlindring i samband med första pneumokockvaccinationen vid tre månaders ålder inom Barnhälsovården.

    Primär frågställning
    1. Leder Emla kräm som smärtlindring till barn i samband med pneumokockvaccination vid tre månaders ålder till lägre smärtpoäng vid användandet av FLACC som smärtskattningsinstrument?

    E.2.2Secondary objectives of the trial
    Secondary objectives
    2. Leads Emla cream as pain relief in connection with pneumococcal vaccination to any difference in the child's heart rate response and saturation?

    3. Leads Emla cream as pain relief that it takes longer before the baby starts crying and does the child cry for a shorter time in connection with vaccination?

    4. Does parents score their child's pain reaction different if the child received Emla cream compared to those who didn´t received any pain relief?
    Sekundära frågeställningar
    2. Leder Emla kräm som smärtlindring i samband med pneumokockvaccination till någon skillnad på barnets pulsreaktion och saturation?
    3. Leder Emla kräm som smärtlindring till att det tar längre tid innan barnet börjar gråta och gråter barnet kortare tid i samband med vaccinationen?
    4. Skattar föräldrar sitt barns smärtreaktion annorlunda om barnet erhållit Emla kräm jämfört med de som inte erhållit någon smärtlindring?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy children, normal birth or are born with sectio after 37 weeks of gestation and who are not admitted to the neonatal unit. Children should only have been with the PKU testing performed routinely at the hospital.
    Inklutionskriterier: Friska barn normal förlösta eller födda med sectio efter graviditetsvecka 37 och som inte vårdats på neonatalavdelning. Barnen ska endast ha varit med om PKU provtagning som utförts rutinmässigt på BB.
    E.4Principal exclusion criteria
    Baby delivered by vacuum extraction or forceps. Children born before gestational week 37. Children in neonatal care and subjected to other testing than PKU. Shoulder dystocia. Children susceptible to methaemoglobinaemia in glucose 6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia. Children with atopic dermatitis because the application time for Emla-plaster should be shortened to 15-30 minutes
    Exclutionskriterier: Barn förlösta med sugklocka eller tång. Barn födda före graviditetsvecka 37. Barn vårdade på neonatalavdelning och utsatta för provtagning efter PKU. Skulderdystrosi. Barn mottagliga för methemoglobinemi med glukos-6-fosfatdehydrogenas brist, medfödd eller idiopatisk methemoglobinemi. Barn med atopisk dermatit på grund av att applikationstiden bör förkortas till 15-30 minuter (FASS, 2008).
    E.5 End points
    E.5.1Primary end point(s)
    Does Emla cream work as pain relief during Pneumococcal vaccination.
    Kommer Emla kräm minska smärtupplevelsen vid pneumokockvaccination.

    E.5.2Secondary end point(s)
    This study will lead to new knowledge about Emla cream and pnemocockal vaccination. The study will give new knowledge how painful pneumocockal vaccination is for the children. If the study showes that Emla cream don´t give enough pain relief during pneumocockal vaccination more studies should be done with other pain relief.
    Studien kommer leda till ny kunskap om Emla kräm och pneumokockvaccination. Med studien kommer ny kunskap om hur smärtsam pneumokockvaccinationen är för barnen. Skulle det med studien visa sig att Emla kräm inte ger tillräcklig smärtlindring vid pneumokockvaccination behöver fler studier göras med annan smärtlindring.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) No
    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 Yes
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Emla kräm och Prevenar 13
    Emla cream and Prevenar 13
    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 concerned2
    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 last visit last subject
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 72
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 72
    F.1.1.5Children (2-11years) No
    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
    The study involves children who are three months old. Children can´t give informed consent, they are dependent of their caregivers.
    I studien inkluderas barn som är 3 månader gamla. De kan inte ge sitt samtycke till att delta i studien utan är beroende av sina vårdnadshavare.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    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)
    Today when children receive pneumococcal vaccination they don´t get any pain relief. 36 of the children in the study will receive Emla cream as pain relief. Emla cream as pain relief is the difference to normal routine.
    Vid pneumokockvaccination idag så smärtlindras inte barnen. I studien kommer 36 barn erhålla Emla kräm som smärtlindring. Emla kräm som smärtlindring är det som skiljer mot normal rutin.
    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 Decision2012-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-16
    P. End of Trial
    P.End of Trial StatusOngoing
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