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    Summary
    EudraCT Number:2020-002908-39
    Sponsor's Protocol Code Number:FEPODPara2020-1
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-22
    Trial results View 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 ConcernedFinland - Fimea
    A.2EudraCT number2020-002908-39
    A.3Full title of the trial
    Detection of paracetamol concentration in blood-, saline- and urine samples with an electrochemical indicator in healthy volunteers - a validation study for a novel technique.
    Parasetamolipitoisuuden määrittäminen sähkökemiallisella mittarilla veri-, sylki- ja virtsanäytteistä vapaaehtoisilla tutkimushenkilöillä – mittarin validointitutkimus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measurement of paracetamol concentration with a novel electrochemical technique from fingerprick-, saline - and urine samples.
    Parasetamolipitoisuuden määrittäminen uudella elektrokemiallisella menetelmällä sormenpää-, sylki- ja virtsanäytteistä.
    A.4.1Sponsor's protocol code numberFEPODPara2020-1
    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 SponsorHelsinki University Hospital
    B.1.3.4CountryFinland
    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 supportBusiness Finland
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Hospital
    B.5.2Functional name of contact pointJohanna Kujala
    B.5.3 Address:
    B.5.3.1Street AddressPL 440
    B.5.3.2Town/ cityHUS
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.6E-mailjohanna.kujala@helsinki.fi
    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 Panadol
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Consumer Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 namePanadol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    This is a laboratory equipment validation study. All subjects are healthy volunteered individuals.
    Kyseessä on uuden lääkeainepitoisuusmittausmenetelmän validaatiotutkimus, joka suoritetaan terveillä vapaaehtoisilla tutkimushenkilöillä.
    E.1.1.1Medical condition in easily understood language
    This is a laboratory equipment validation study. All subjects are healthy volunteered individuals.
    Tutkimuksessa pyritään selvittämään, onko uudentyyppinen lääkainepitoisuusmittari luotettava verrattuna käytössä olevaan menetelmään.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples.
    We will recruit 12 healthy volunteers, ages 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 12 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis.
    Tutkimuksen tarkoitus on selvittää, onko uudentyyppinen elektrokemiallinen mittausmenetelmä luotettava parasetamolipitoisuuden määrityksessä verrattuna standardimenetelmään (High Performance Liquid Cromatography – tandem mass spectrometry). Tutkimukseen rekrytoidaan 12 tervettä vapaaehtoista, iältään 18-45 vuotta. Heille annostellaan 1 g parasetamolia suun kautta. Tutkimuksen aikana tietyissä aikapisteissä määritellään parasetamolipitoisuus sylki-, sormenpää-, virtsa- ja laskimoverinäytteistä. Tulokset analysoidaan molemmilla mittausmenetelmillä.
    E.2.2Secondary objectives of the trial
    Despite of vast use, the mechanism of action of parasetamol is not completely understood. The central serotonergic system may play a role.
    Endocannabinoid system is a group of lipid mediators, that possibly is involved in mediating paracetamol effect to serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid metabolics.
    In this study we will try to assess changes in endocannabinoid system by looking into serum lipidomics in order to understand the mechanism of action of paracetamol.
    Huolimatta laajasta käytöstä parasetamolin vaikutusmekanismi on epäselvä. Sentraalisella serotonergisellä järjestlemällä voi olla keskeinen rooli.
    Endokannabinoidijärjestelmä on ryhmä lipidivälittäjäaineita, jotka säätelevät ionikanavien ja hermovälittäjäaineiden metaboliaa. Tämä järjestelmä on mahdollisesti välittämässä parasetamolin vaikutusta serotonergiseen systeemiin. Endokannabinoidijärjestelmää on mahdollista tutkia määrittämällä seerumin lipidejä.
    Tässä tutkimuksessa määrittelemme seerumin lipidomin muutoksia parasetamolin annostelun seurauksena tietyissä aikapisteissä. Näytteet otetaan parasetamolin pitoisuusmääritysten yhteydessä sekä yksi ylimääräinen näyte 24 tunnin kuluttua parasetamolin annostelusta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent. Healthy, normal weight, age 18-45. Must pass medical examination prior to inclusion.
    • allekirjoitettu suostumus
    • ikä 18-45 vuotta
    • terve
    • hyväksyttävät arvot laboratoriotutkimuksissa (määritetään HUSLabissa): hemoglobiini vähintään viitealueen alarajalla (miehet 134 g/l, naiset 117 g/l), muissa tuloksissa (B-PVKT, P-ALAT, P-AFOS, P-GT, P-Krea, P-K, P-Na) hyväksytään vähäisiä normaaliarvoista poikkeavia arvoja, jotka tutkijalääkärin arvion mukaan ovat kliinisesti merkityksettömiä. Naisilla raskaustestin (P-hCG-tot) tulee olla negatiivinen.
    • normaali verenpaine
    • ei viitteitä päihteiden väärinkäytöstä seulontatutkimuksessa
    E.4Principal exclusion criteria
    Not considered healthy.
    Alcohol, tobacco, or illegal substance use.
    Regular medication incl contraceptives
    Pregnancy, planned pregnancy or lactation
    Participation in another clinical trial within 3 monts
    Blood donation within 3 monts.
    BMI < 18.5 or > 30
    • merkittävä sairaus
    • riskirajan ylittävä alkoholinkäyttö
    • tupakointi
    • e-pillerit tai muu säännöllinen lääkitys
    • raskaus, sen suunnittelu tai imetys
    • edellisestä lääketutkimuksesta vähemmän kuin 3 kuukautta
    • verenluovutuksesta vähemmän kuin 3 kuukautta
    • hankalasti kanyloitaviksi arvioidut laskimot
    • paino alle 50 kg, painoindeksi (BMI) alle 18.5 tai yli 30
    E.5 End points
    E.5.1Primary end point(s)
    Validation of the novel laboratory analysis method.
    Uuden elektrokemiallisen lääkainepitoisuusmenetelmän luotettavuuden arviointi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 hours post adminitration of paracetamol
    12 tuntia lääkkeen annostelusta
    E.5.2Secondary end point(s)
    Changes in serum lipidomics after administration of paracetamol.
    Seerumin lipidomiikkamäärityksen muutokset parasetamolin annostelun seurauksena 24 tunnin kuluessa parasetamolin annosta.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours post administration of paracetamol
    24 tuntia parasetamolin annostelun jälkeen.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other No
    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
    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 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: 12
    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 state12
    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
    Ei
    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 Decision2020-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-06
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