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    Summary
    EudraCT Number:2016-002065-66
    Sponsor's Protocol Code Number:OY102016
    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:2016-11-02
    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 number2016-002065-66
    A.3Full title of the trial
    Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population
    Nenään annosteltava deksmedetomidiini lastenreumapotilaiden toimenpiteen aikaisena rauhoittavana lääkityksenä
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population
    A.3.2Name or abbreviated title of the trial where available
    Deksmedetomidiini toimenpiteen aikaisena rauhoittavana lääkityksenä
    A.4.1Sponsor's protocol code numberOY102016
    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 SponsorMiikka Tervonen
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    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.IMP: 2
    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 Livopan
    D.2.1.1.2Name of the Marketing Authorisation holderAGA AB
    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 nameLivopan
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 10024-97-2
    D.3.9.3Other descriptive nameNITROUS OXIDE
    D.3.9.4EV Substance CodeSUB03447MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    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
    All the patients from 1year to 18 years of age who have been diagnosed by a pediatric rheumatologist to have a joint inflammation needing intra-articular corticosteroid injection in 1 to 5 joints
    Potilasaineisto koostuu OYS lastenklinikan reumatologisen poliklinikan 1-18 vuotiaista potilaista, jotka tarvitsevat nivelensisäistä kortikosteroidipistosta. Päätöksen injektiohoidon tarpeellisuudesta tekee hoitava lastenreumatologi. Kutsumme tutkimukseen mukaan potilaita, joilla on vähintään yksi, mutta enintään 5 pistettävää niveltä.
    E.1.1.1Medical condition in easily understood language
    Pediatric patients with joint inflammation requiring injection therapy are applicable to this study
    Tutkimukseen osallistuvat potilaat ovat lapsia, joilla on pistoshoitoa vaativa niveltulehdus
    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 of this study is to evaluate the efficacy of intranasal dexmedetomidine sedation during intra-articular injection therapy. We compare intranasal dexmedetomidine with nitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric patients.
    In earlier studies the median VAS during intra-articular corticosteroid injections with patients recieving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.
    Nitrous oxide sedation requires spesific equipment for the delivery of the nitrous oxide. Spesific equipment is also needed for the inhalation gas removal. Intranasal dexmedetomidine is given by a syringe via nasal plug that atomizes the drug.
    Tutkimuksen tarkoituksena on selvittää, onko nenäonteloon annosteltava deksmedetomidiini toimiva ja riittävä lääkitys nivelen sisäisten kortikosteroidi-injektioiden yhteydessä lasten reumapoliklinikalla. Vertaamme lääkitystä ilokaasusedaatioon, joka on aiemmin osoittautunut turvalliseksi ja tehokkaaksi sedaatiomuodoksi lastenreumapotilaiden nivelinjektioiden aikana.
    Ilokaasulla sedatoiduilla potilailla nivelinjektiot ovat onnistuneet hyvin ja potilaiden VAS pisteytyksen mediaaniarvo on ollut tasoa 3 (Uziel Y ym. 2008). Tutkimushypoteesimme on, että intranasaalisella deksmedetomidiinilla saavutetaan parempi kivunhoito- ja sedaatio siten, että potilaan kipu VAS pisteytys on yhden mittayksikön verran matalampi.
    Ilokaasun annosteluun tarvitaan erityislaitteistoa ja lisäksi toimenpidetiloissa tulee olla riittävä kaasunpoisto. Deksmedetomidiini annetaan tavallisella ruiskulla nenätulpan avulla. Nenätulppa muuttaa nestemäisen lääkkeen sumutteeksi.
    E.2.2Secondary objectives of the trial
    We also assess the safety profile and adverse effects of intranasal
    dexmedetomidine. The efficacy of intranasal dexmedetomidine sedation is assessed by a stratified sedation scale. Cost effectiveness of both treatments is evaluated.
    Arvioimme tutkimuksessamme nenään annosteltavan deksmedetomidiinin turvallisuutta ja haittavaikutuksia lapsipotilailla. Arvioimme nenäonteloon annosteltavan deksmedetomidiinin rauhoittavaa tehoa arvioimalla potilaiden sedaatiota stratifioiduilla sedaatioasteikoilla. Lisäksi arvioimme molempien sedaatiomuotojen kustannuksia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    -Patients from 1year to 18 years of age
    -A joint inflammation in 1-5 joints requiring intra-articular corticosteroid injection diagnosed by pediatric rheumatologist
    Kutsumme tutkimukseemme 1-18 vuotiaita lapsia, joilla on lastenreumatologin toteama nivelensisäistä kortikosteroidi-injektiohoitoa vaativa niveltulehdus 1-5 nivelessä.
    E.4Principal exclusion criteria
    Patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.
    Tutkimukseen ei oteta mukaan potilaita, jotka ovat alle 1 vuotta, yli 18 vuotta tai jotka tarvitsevat injektioita yli 5 niveleen
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the VAS (Visual Analog Scale) pain score during
    the injection procedure.
    Ensisijainen vastemuuttuja on potilaiden kivuliaisuus toimenpiteen aikana VAS-asteikolla mitattuna.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The VAS score is evaluated during the procedure and with a
    questionnaire filled by the patient and parent after the procedure.
    VAS pisteytystä arvioidaan toimenpiteen aikana ja toimenpiteen jälkeen potilaan ja vanhemman täyttämällä kyselylomakkeella.
    E.5.2Secondary end point(s)
    Patients sedation level is evaluated with stratified sedation scales. Blood pressure, heart rate, respiratory rate and oxygen saturation are monitored during the procedure. Capnography readings are measured to identify possible events of apnea. All the adverse effects are noted and treated if necessary by the health care staff. Costs of the sedation protocols are evaluated.
    Potilaan sedaation syvyyttä arvioidaan lapsipotilaille stratifioiduilla sedaatioasteikoilla. Potilaan verenpainetta, sykettä, hengitysfrekvenssiä happisaturaatiota ja vointia tarkkaillaan toimenpiteen ajan. Potilaan toimenpiteenaikaista hengitystä seurataan kapnografiakäyrää seuraamalla, joka tunnistaa potilaan mahdolliset apneat. Lisäksi vertailemme tutkimuksessa käytettävien sedaatiomuotojen kustannuksia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary outcomes are evaluated during the procedure and afterwards with a questionnaire.
    Muita päätetapahtumia arvioidaan toimenpiteen aikana ja sen jälkeen täytettävällä kyselylomakkeella.
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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
    Study enrollment will be continued until 44 patients are treated with both sedation methods in this cross over trial.
    Tutkimuksemme on vaihtovuoroinen tutkimus, jota jatketaan kunnes 44 potilasta on hoidettu molempia sedaatiomuotoja käyttäen.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 109
    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: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state109
    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)
    Normal treatment of juvenile idiopathic arthritis
    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 Decision2016-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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