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    Summary
    EudraCT Number:2012-000839-54
    Sponsor's Protocol Code Number:SMi-MW-12
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-000839-54
    A.3Full title of the trial
    The effect of late naloxon-infusion on secondary hyperalgesia after a first degree burn injury
    Effekten af sen naloxon-infusion på sekundær hyperalgesi efter en førstegrads varmeskade
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of late infusion of Naloxon, a drug that neutralizes the effect of morphine, on pain sensitivity after a first degree burn injury
    Effekten af sen indgift at af naloxon, et stof der ophæver morfins virkning, på smerteoverfølsomhed efter en førstegrads varmeskade

    A.4.1Sponsor's protocol code numberSMi-MW-12
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointKaren Lisa Hilsted
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4535459502
    B.5.5Fax number+4535452950
    B.5.6E-mailkaren.lisa.hilsted@rh.regionh.dk
    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 Yes
    D.2.1.1.1Trade name Naloxon
    D.2.1.1.2Name of the Marketing Authorisation holderB.Braun Medical
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNaloxon
    D.3.2Product code V03AB15
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALOXONE
    D.3.9.1CAS number 465-65-6
    D.3.9.4EV Substance CodeSUB09142MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Induced pain in volunteers
    Induceret smerte hos frivillige forsøgspersoner
    E.1.1.1Medical condition in easily understood language
    Induced pain in volunteers
    Påført smerte hos frivillige forsøgspersoner
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to investigate if the administration of naloxon can reinduce secundary hyperalgesia areas after a first degree burn injury in volunteers
    Formålet er at undersøge om administration af naloxon, kan re-introducere sekundære hyperalgesi-arealer efter en førstegrads varmeskade hos frivillige forsøgspersoner.
    E.2.2Secondary objectives of the trial
    None
    Ingen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy
    Age betwen 20 and 35
    Volunteers that have given there written concent to participate in the clinical trial and understand the trial.
    Urinary test with no trace of opioids
    Negative pregnancy test
    ASA 1-2
    Body mass index (BMI): 18 < BMI < 30
    • Sund og rask
    • Alder  20 år og  35 år
    • Frivillige forsøgspersoner, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået denne.
    • Urinprøve uden spor af opioider (morfin,methadon, buprenorphin)
    • Negativ graviditetstest
    • ASA 1-2
    • Body mass index (BMI): 18 < BMI < 30
    E.4Principal exclusion criteria
    Volunteers that can not cooperate
    Volunteers that do not understand and read danish
    Women who are planning to be pregnant, are pregnant or are breastfeeding
    Women how do not use birthcontrol
    Have been in another clinical trial the last 60 days
    Any form of injury or any other influence of the nerves on the calf
    Any neurological disease
    use of any psychoactive drugs
    Abuse of alcohol or drug
    Chronical pain
    regular use of analgesia (more than twice a week)
    Know allergy to morphine or other morphine drug incl. Naloxon
    Skin lesion on the calf
    Has taken medicin prescription a week before the trial
    Has taken over the counter medicin 48 hours before the trial
    Psychological instabel - investigators evaluation
    • Patienter som ikke kan samarbejde til undersøgelsen.
    • Patienter som ikke forstår eller taler dansk
    • Kvinder der planlægger graviditet, er gravide, eller ammer
    • Kvinder, der ikke anvender præventionsmidler (p-piller eller IUD [intra uterine device])
    • Deltaget i andet lægemiddelforsøg de seneste 60 dage
    • Nervepåvirkning i det ipsilaterale og det kontra-laterale måleområde (læggene), fx. følger efter traume, discusprolaps osv.
    • Neurologisk sygdom.
    • Brug af psykofarmica
    • Alkohol- og/eller medicinmisbrug – efter investigators skøn.
    • Kronisk smertetilstand
    • Regelmæssigt brug af analgetika (> 2 gange per uge)
    • Kendt allergi overfor morfin eller morfin-lignende stoffer (inklusive naloxon)
    • Hudlæsioner på måleområderne (læggene).
    • Indtagelse af receptpligtig medicin 1 uge inden forsøget.
    • Indtagelse af håndkøbs medicin op til 48 timer inden forsøget (med undtagelse af antikonceptiva)
    • Efter investigators vurdering ikke er egnet til deltagelse i forsøget (eks. psykomotorisk ustabile)
    • Allergi over for de i undersøgelsen anvendte stoffer.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is the areas of the secondary hyperalgesia

    Primære effektparametre er sekundære hyperalgesi arealer
    E.5.1.1Timepoint(s) of evaluation of this end point
    73 hours after induced burn injury
    73 timer efter brandskaden er induceret
    E.5.2Secondary end point(s)
    WDT - Warm - Detection Threshold
    HPT - Heat Pain Threshold
    MPT - Mecanic Pain Threshold
    HADS - Hospital Anxiety and Depression Scale
    Sekundære effektparametre er termale tærskler
    • WDT- varme detektiontærskel
    • HPT – varme smertetærskel
    Mekaniske smertetærskler
    • MPT – mekanisk smertetærskel
    Psykometriske data
    • HADS – Hospital Angst og Depressions Skala
    • PCS – Pain Catastrophizing Scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 hours after incuced burn injury
    3 timer efter induceret brandskade
    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 No
    E.6.6Pharmacokinetic No
    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) Yes
    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 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 trial2
    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
    73 hours after burn injury at visit 4
    73 timer efter varmeskaden er induceret ved besøg 4
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 22
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    women of child-bearing potential using contraception
    Kvinder i den fertile alder som anvender antikonception
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    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
    Ingen
    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 Decision2012-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-16
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