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    Summary
    EudraCT Number:2017-001297-41
    Sponsor's Protocol Code Number:OY072017
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-15
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-001297-41
    A.3Full title of the trial
    Intranasal dexmedetomidine sedation and analgesia during minor procedures in the pediatric emergency room : Randomized double-blinded clinical trial
    Nenäsumutteena annosteltava deksmedetomidiini kivunhoitona ja rauhoittavana lääkkeenä lasten päivystyksellisissä pientoimenpiteissä: Satunnaistettu, kaksoissokkoutettu kliininen koe
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intranasal dexmedetomidine sedation and analgesia during pediatric emergency room procedures
    Nenäsumutteena annosteltava deksmedetomidiini kivunhoitona ja rauhoittavana lääkkeenä lasten päivystyksellisissä pientoimenpiteissä
    A.3.2Name or abbreviated title of the trial where available
    INDEXER
    A.4.1Sponsor's protocol code numberOY072017
    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 SponsorOulu 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 supportOulu university hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulu University Hospital
    B.5.2Functional name of contact pointLasten ja nuorten klinikka
    B.5.3 Address:
    B.5.3.1Street AddressPL 23 OYS
    B.5.3.2Town/ cityOulu
    B.5.3.3Post code90029
    B.5.3.4CountryFinland
    B.5.6E-mailouti.peltoniemi@ppshp.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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    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 nameDexdor
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.4EV Substance CodeSUB07037MIG
    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 placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our study if they would seem to benefit from a sedative drug during the procedure.
    Tarjoamme mahdollisuutta osallistua tutkimukseen OYS lastenklinikan potilaille, jotka hyötyisivät heille suunnitellun pienen päivystyksellisen toimenpiteen aikaisesta rauhoittavasta lääkityksestä. Tuollaisia toimenpiteitä ovat esimerkiksi päivystyksellinen lannepisto ja laskimokanyylin asentaminen.
    E.1.1.1Medical condition in easily understood language
    Patients with any medical condition requiring a minor procedure such as i.v. cannulation or lumbar puncture are asked to participate in our study.
    Potilaat, joille tehdään pieni toimenpide, kuten laskimokanyylin laitto tai aivo-selkäydinnestenäytteen otto voivat osallistua tutkimukseemme.
    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
    Our objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room.
    Selvitämme, onko nenäsumutteena annosteltava deksmedetomidiini turvallinen ja tehokas rauhoittava lääkitys levottomille lapsipotilaille pienten päivystyksellisten toimenpiteiden, kuten laskimo-kanyloinnin ja lannepiston, aikana. Tutkimuksemme on satunnaistettu, lumekontrolloitu kaksoissok-kotutkimus.
    E.2.2Secondary objectives of the trial
    The duration of sedative effects of 1µg/kg intranasal dexmedetomidine spray is assessed.
    Selvitämme tutkimuksessamme myös kuinka pitkään potilaat ovat sedatoituneita 1µg/kg deksmedetomidiini-annoksella.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pediatric patients aged 1-12 years at the Oulu University Hospital emergency room who would benefit from sedative medication during small painful procedures like i.v. cannulation or lumbar puncture are asked to take part in our study
    Tarjoamme mahdollisuutta osallistua tutkimukseen OYS lastenklinikan lastenklinikan potilaille, jotka hyötyisivät heille suunnitellun pienen päivystyksellisen toimenpiteen aikaisesta rauhoittavasta lääkityksestä. Tuollaisia toimenpiteitä ovat esimerkiksi päivystyksellinen lannepisto ja laskimokanyylin asentaminen. Tutkimukseen voivat osallistua kaikki Oulun yliopistolli-sen sairaalan ja Kainuun keskussairaalan lastenklinikassa hoidossa olevat 1-12 –vuotiaat lapset
    E.4Principal exclusion criteria
    Exclusion criteria include:
    -Allergy to dexmedetomidine or any supplementary elements of the Dexdor®-solution
    -II or III degree AV-blockage without pacemaker
    -Uncontrollable hypotension
    -Stroke
    -Critically ill patients who are admitted to the PICU
    -Patients with clear cardiac or respiratory dysfunction
    -Lowered level of consciousness
    -Patients with increased risk of apnoeic events due to neurologic or metabolic conditions or extreme obesity

    A single patient can only participate in this study once.
    Poissulkukriteereinä ovat yliherkkyys deksmedetomidiinille tai jollekin Dexdor®-valmisteen apuaineista, II-III asteen AV-katkos ilman tahdistinta, kontrolloimaton hypotensio tai akuutti aivoverenkiertohäiriö. Kriittisesti sairaat potilaat, jotka otetaan tehovalvontaan tai tehohoitoon äkillisen sairauden vuoksi, ja joilla on selvä happeutumis- tai verenkiertohäiriö tai alentunut tajunnan taso sairaalaan tullessa, poissuljetaan tutkimuksesta. Lisäksi mahdollisen apneariskin poissulkemiseksi tutkimukseen eivät voi osallistua vaikeasti neurologisesti sairaat, mahdollisesti hengitystoimintaan vaikuttavaa metabolista tautia sairastavat tai vaikeasti ylipainoiset potilaat. Yksi potilas voi osallistua tutkimukseen vain yhden kerran, vaikka toimenpiteitä tehtäisiin useampana päivänä.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point in this study is the success of the procedure at the first attempt.
    Päävastemuuttuja on toimenpiteen onnistuminen ensimmäisellä yrityksellä.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The success rate of the first attempt of the procedure is evaluated at the end of the first attempt of the procdure.
    Toimenpiteen onnistumista ensimmäisellä yrityksellä arvioidaan ensimmäisen yrityksen jälkeen.
    E.5.2Secondary end point(s)
    Secondary end points include:
    -The duration of the procedure
    -Parents assessment of the patients comfortability during the procedure
    -Patients assessment of the experienced pain with Visual Analog Scale
    -Assessment of pain levels of the patient with FLACC-scores
    -Assessment of sedation levels of the patient with Comfort-B-scores
    -Duration of crying
    -The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo
    -Blood pressure is measured by manometer
    -Respiratory rate is assessed by capnometry
    -Oxygen saturation is measured by pulse oxymetry
    -Heart rate is measured by ECG
    Toissijaisina vastemuuttujina tutkimme toimenpiteen kokonaiskestoa (nenäsumute - toimenpide saatu tehtyä onnistuneesti), vanhempien arviota tilanteen miellyttävyydestä Likertin asteikolla, lääkärin ja potilaan omaa arviota potilaan kivuliaisuudesta (VAS; Visual Analog Scale, FLACC) ja lääkärin arviota sedaatiotasosta lapsille suunnitellulla sedaatioasteikolla (COMFORT-B). Lisäksi kirjaamme lapsen itkun keston minuutteina hetkestä, kun lapsi saa nenään tutkimuslääkkeen siihen hetkeen, kun toimenpide on saatu onnistuneesti tehtyä. Erikseen vanhemmilta ja lasten sairaanhoitajalta kysytään, arvioivatko he lapsen saaneen vaikuttavaa lääkeainetta vai ei. Tutkimuslääkäri seuraa potilaan vointia, verenpainetta, syketaajuutta, hengitystaajuutta ja happisaturaatiota ennen lääkkeen antoa 10 minuutin ajan, lääkkeen annon jälkeen vuoteen vieressä 30 minuutin ajan 5 minuutin välein, toimenpiteen aikana 5 minuutin välein ja toimenpiteen jälkeen vielä 10 minuutin välein, kunnes on kulunut vähintään kaksi tuntia lääkkeen annosta ja potilas on selkeästi herännyt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The vital parameters, FLACC-scores, sedation level are evaluated in every 5 minutes starting 10 minutes before the administration of the drug and continuing until 2 hours of the administration of study drug or the patient has completely woken up. VAS scores are asked after the patients have woken up. The parents and the nurses assessment of the pain levels are asked after the procedure.
    Tutkimuslääkäri seuraa potilaan vointia, kivuliaisuutta (FLACC), sedaatioastetta (Comfort-B), verenpainetta, syketaajuutta, hengitystaajuutta ja happisaturaatiota ennen lääkkeen antoa 10 minuutin ajan, lääkkeen annon jälkeen vuoteen vieressä 30 minuutin ajan 5 minuutin välein, toimenpiteen aikana 5 minuutin välein ja toimenpiteen jälkeen vielä 10 minuutin välein, kunnes on kulunut vähintään kaksi tuntia lääkkeen annosta ja potilas on selkeästi herännyt. Potilaan arvio kivuliaisuudesta VAS asteikolla kysytään kun potilas on herännyt. Vanhempien ja hoitajan arvio toimenpiteen onnistumisesta kysytään toimenpiteen jälkeen.
    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 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) Yes
    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 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) 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
    The trial is ended when a total of 112 patients have been recruited and the last patient has been followed up completely.
    Tutkimus päättyy kun 112 potilasta on rekrytoitu ja viimeisimmän potilaan seuranta on valmis.
    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 months
    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: 112
    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: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 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 state112
    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
    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 Decision2018-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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