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    Summary
    EudraCT Number:2015-002210-71
    Sponsor's Protocol Code Number:38RC15.154
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-002210-71
    A.3Full title of the trial
    Impact of dexmedetomidine on preventive noninvasive ventilation in thoracic trauma
    Impact de la dexmedetomidine sur la ventilation non invasive préventive chez le traumatisé thoracique
    A.3.2Name or abbreviated title of the trial where available
    VENDETTA
    VENDETTA
    A.4.1Sponsor's protocol code number38RC15.154
    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 SponsorUniversity Hospital Grenoble
    B.1.3.4CountryFrance
    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 Hospital Grenoble
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Grenoble
    B.5.2Functional name of contact pointDr TROUVE-BUISSON
    B.5.3 Address:
    B.5.3.1Street AddressService de Réanimation polyvalente Chirurgicale - CS 10217
    B.5.3.2Town/ cityGRENOBLE
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number3304 76 76 52 95
    B.5.5Fax number3304 76 76 52 21
    B.5.6E-mailTTrouve-buisson@chu-grenoble.fr
    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 AuthorisationFrance
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Thoracic trauma
    Traumatisés thoraciques
    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
    Compare the length of the sessions of VNI under DEX and placebo in the thoracic trauma patient
    Comparer la durée des séances de VNI sous DEX et sous placebo chez le patient traumatisé thoracique
    E.2.2Secondary objectives of the trial
    1) To compare the safety of the patient during the session of VNI in DEX through hetero assessment scales (RASS) and self-assessment (EVA dyspnea, pain EVA, analgesic consumption during the sessions).
    2) Compare the effectiveness of the VNI on arterial blood gases according to sedation
    3) Evaluate the safety: a collection of the number of adverse events attributable to DEX at meetings.
    1) Comparer la tolérance du patient lors de la séance de VNI sous DEX via des échelles d'hétéro évaluation (RASS) et d'autoévaluation (EVA dyspnée, EVA douleur, consommation d'antalgique pendant les séances).
    2) Comparer l'efficacité de la VNI sur la gazométrie artérielle en fonction de la sédation
    3) Evaluer la sécurité : recueil du nombre d'effets indésirables imputables à la DEX au cours des séances.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient hospitalized in intensive care or USC
    • Patient with a closed chest trauma not intubated (TTS score> 6)
    • Patient row to social security
    • Major Patient
    • Patient hospitalisé en réanimation ou USC
    • Patient présentant un traumatisme thoracique fermé non intubé (score TTS > 6)
    • Patient affilé à la sécurité sociale
    • Patient majeur
    E.4Principal exclusion criteria
    • EVA Rest> 3
    • Agitation with RASS> 2
    • Patient on DEX or treated with an alpha 2 agonist in the last 8 hours
    • Patients on home VNI (except for VS-PPC OSA)
    • analgesia by epidural catheter
    • Long-term treatment with neuroleptics
    • Contraindications to the VNI
    • Contraindications to the DEX
    • EVA repos>3
    • Agitation avec RASS>2
    • Patient sous DEX ou ayant reçu un alpha 2 agoniste dans les 8 dernières heures
    • Patient sous VNI à domicile (sauf VS-PPC pour SAOS)
    • Analgésie par Cathéter péridural
    • Traitement au long cours par neuroleptiques
    • Contre-indications à la VNI
    • Contre-indication à la DEX
    E.5 End points
    E.5.1Primary end point(s)
    Duration of VNI sessions with and without DEX (minutes)
    Durée des séances de VNI avec et sans DEX (en mn)
    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 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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state20
    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
    Non
    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 Decision2015-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-01
    P. End of Trial
    P.End of Trial StatusOngoing
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