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    Summary
    EudraCT Number:2013-000205-23
    Sponsor's Protocol Code Number:14012013
    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:2013-03-27
    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 number2013-000205-23
    A.3Full title of the trial
    The analgesic effects of melatonin: A randomized, placebo-controlled, double-blinded study on healthy volunteers
    Melatonins analgetiske effekter: et randomiseret, dobbeltblindet placebokontrolleret overkrydsningsstudie på raske forsøgspersoner
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The analgesic effects of melatonin. A study on healthy volunteers
    Melatonins smertestillende effekter: et studie på raske forsøgspersoner
    A.3.2Name or abbreviated title of the trial where available
    The analgesic effects of melatonin
    Melatonins smertestillende effekter
    A.4.1Sponsor's protocol code number14012013
    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 SponsorDepartment of surgery, Herlev Hospital
    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 supportUniversity of Copenhagen
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of surgery, Herlev Hospital
    B.5.2Functional name of contact pointLars Peter Holst Andersen
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number004531518908
    B.5.5Fax number004538683602
    B.5.6E-mailLars.Peter.Holst.Andersen@regionh.dk
    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 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 nameMelatonin
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,4 to 4mg/ml
    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 placeboConcentrate and solvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Heat injury in healthy volunteers
    E.1.1.1Medical condition in easily understood language
    A light heat injury in healthy volunteers
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Quantitative sensory testing in the heat injury area after melatonin/placebo-treatment.

    1. Pain (VAS) during heat injury and areas of hyperalgsia

    2. Pharmacokinetic and pharmacodynamic variables, plasma-concentration profiles, and hysteresis-curves with plasma-concentration (during onset og off-set) vs. effekt-variables
    Kvantitativ sensorisk testning i det varmeskadede område efter melatonin/placebo-behandling.

    De primære outcome-parametre er en dosisafhængig påvirkning af smerterne under varmeskade (AUC7 min-VAS), samt påvirkning af de sekundære hyperalgesi-arealer.

    Outcomes
    Bestemmelse af traditionelle farmakokinetiske og farmakodynamiske variabler, plasma-koncentrations profiler samt hysterese-kurver med plasma-koncentration (under onset og off-set) vs. effekt-variabler er de centrale mål i studiet.
    E.2.2Secondary objectives of the trial
    Erythema/oedema, and thermal and mechanical thresholds of quantitative sensory testing
    Erythem/ødem, samt påvirkning af termale og mekaniske tærskler.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy males aged between 20 and 40 years
    Raske mandlige forsøgspersoner med alder mellem 20-40 år
    E.4Principal exclusion criteria
    Under aged/minors

    Does not speak or understand danish

    Alcol/medicin abuse

    Prior QST-trial within the last 2 month

    Prior medical trail within the last month

    Serious comorbidity(ASA-class 3-4)

    Chronic pain(defined by analgesic treatment)

    Shift-work or night work within the last 14 days

    Known sleep-disorder
    Umyndig

    Forstår ikke dansk i tale eller skrift

    Aktuelt alkohol/medicinmisbrug.

    Deltagelse i QST-forsøg inden for de seneste 2 mdr. før første forsøgsdag

    Deltagelse i medicinske forsøg inden for de seneste 1 mdr. før første forsøgsdag

    Alvorlig behandlingskrævende komorbiditet (ASA-klasse 3+4) eller behandlingskrævende psykisk sygdom

    Tilstand med kroniske smerter (defineret ved daglig analgetisk behandling)

    Skifteholdsarbejde eller natarbejde i øvrigt i 14 dage op til forsøget.

    Kendt diagnosticeret søvnforstyrrelse
    E.5 End points
    E.5.1Primary end point(s)
    Pain(VAS) during heat injury and areas of hyperalgesia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline + 1,2,3 hours postburn
    E.5.2Secondary end point(s)
    Erythema and thermal/mechanical thresholds
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline + 1,2,3 hours postburn
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    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 trial3
    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 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 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: 36
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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)
    No post-trial treatment
    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 Decision2013-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-08
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