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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-015529-35
    Sponsor's Protocol Code Number:0918703
    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:2009-09-07
    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 number2009-015529-35
    A.3Full title of the trial
    Prise en charge pharmacologique de l’anxiété et de la douleur chez les patients qui souffrent en situation d’urgence traumatique préhospitalière : étude randomisée contrôlée en double-aveugle.
    A.4.1Sponsor's protocol code number0918703
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU TOULOUSE
    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 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 ATARAX
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA
    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 nameATARAX
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboInjection*
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    douleur en situation d’urgence traumatique préhospitalière
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10065016
    E.1.2Term Post-traumatic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Montrer l’efficacité de l’hydroxyzine combinée à un traitement morphinique de référence sur la douleur aiguë sévère d’origine traumatique.
    E.2.2Secondary objectives of the trial
    - Améliorer le délai d’analgésie
    - Etudier les relations entre
    (a) niveau de douleur exprimé par le patient le jour même de l’admission au service d’urgence,
    (b) niveau de douleur exprimé deux jours et 3 semaines après l’hospitalisation par le patient,
    (c) degré de gravité du trouble, estimé par l’urgentiste à partir de la CCMU (Classification Clinique des Malades des Urgences en préhospitalier),
    (d) diverses caractéristiques des patients dont le niveau d’anxiété générale, le niveau d’anxiété au moment de l’évaluation de la douleur, et le niveau d’anxiété spécifique vis à vis de la maladie et des interventions médicales.
    - Réduire la proportion de patients douloureux et anxieux en fin d’intervention SMUR
    - Evaluer les effets indésirables
    - Evaluer la satisfaction du patient et de l’investigateur
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Majeurs (≥ 18 ans).
    2) Ayant une douleur aiguë intense (≥ 6/10 sur une EN), d’origine traumatique exclusivement.
    3) Bénéficiant d’une prise en charge préhospitalière par un médecin du SMUR adultes du CHU de Toulouse.
    4) Ayant signé un consentement éclairé au moment de l’inclusion ou à postériori (article L.1122-1-2 de la loi n°2004-806 du 9 août 2004).
    5) Affiliés à un régime de sécurité sociale ou équivalent
    E.4Principal exclusion criteria
    1) Les patients connus allergiques à la morphine ou à l’hydroxyzine (*)
    2) Le refus du patient de participer à l’étude
    3) La femme enceinte, allaitante, ou en âge de procréer sans contraception efficace (*)
    4) L’épilepsie non contrôlée (*), et les contre indications liées à l'effet anticholinergique avec risque de glaucome par fermeture de l'angle et risque de rétention urinaire lié à des troubles urétroprostatiques.
    5) Les patients présentant des difficultés de communication ou de compréhension ou endormis non réveillables
    6) Les patients ayant une insuffisance ou une défaillance circulatoire, neurologique, respiratoire, rénale ou hépatique sévère avérée ou en situation clinique engageant le pronostic vital (*)
    7) La prise concomitante de substances (moins de 6 heures) pouvant fausser l’état de conscience ou le jugement (sédatifs, alcool, …) (*)
    8) Les patients dont la CCMU (classification clinique des malades des urgences) est de 4 (situation pathologique engageant le pronostic vital. Prise en charge ne comportant pas de manœuvres de réanimation immédiate) ou 5 (situation pathologique engageant le pronostic vital. Prise en charge comportant la pratique immédiate de manœuvres de réanimation)
    9) La prise récente d’antalgiques (moins de 6 heures), comprenant paracétamol, AINS, aspirine à dose analgésique, néfopam, morphinique faible et fort et d’anxiolytiques, comme les benzodiazépines, les antihistaminiques, les carbamates. (*)
    10) Les patients sous sauvegarde de justice, sous tutelle ou sous curatelle
    11) Les patients participant à une autre étude pendant la durée de leur prise en charge par le médecin du SAMU
    E.5 End points
    E.5.1Primary end point(s)
    Calcul de la proportion de patients analgésiés 15 minutes après le début de la prise en charge. L’analyse de l’analgésie sera effectuée à partir du score d’échelle numérique (EN), sur une échelle graduée de 0 (pas de douleur) à 10 (douleur maximale imaginable). De manière consensuelle, un patient est considéré comme analgésié s’il exprime un score de 3 ou moins à l’EN. Le délai retenu dans le cadre de l’urgence pré hospitalière pour l’analgésie doit être le plus bref possible (afin de pouvoir mobiliser puis transporter les patients aussi rapidement que possible dans de bonnes conditions d’analgésie), ainsi nous prendrons le délai de 15 minutes pour évaluer notre critère principal.
    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 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 Yes
    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 Information not present in EudraCT
    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
    la fin de l'étude correspond au dernier suivi du dernier patient inclus
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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 state140
    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)
    La prise en charge des patients à la fin de leur traitement à l'essai ne diffère pas du traitement habituel dans la prise en charge de la douleur post-traumatique
    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 Decision2009-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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