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    The EU Clinical Trials Register currently displays   35513   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001452-28
    Sponsor's Protocol Code Number:RBHP_2014_CLAVELOU_2
    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:2015-06-17
    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 number2014-001452-28
    A.3Full title of the trial
    .
    IMPACT DE L’INHALATION D’UN MELANGE EQUIMOLAIRE OXYGENE – PROTOXYDE D’AZOTE (MEOPA) SUR LA DOULEUR ET L’ANXIETE DURANT UNE PONCTION LOMBAIRE : ETUDE CONTROLEE, RANDOMISEE, EN DOUBLE AVEUGLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    .
    IMPACT DE L’INHALATION D’UN MELANGE EQUIMOLAIRE OXYGENE – PROTOXYDE D’AZOTE (MEOPA) SUR LA DOULEUR ET L’ANXIETE DURANT UNE PONCTION LOMBAIRE : ETUDE CONTROLEE, RANDOMISEE, EN DOUBLE AVEUGLE
    A.3.2Name or abbreviated title of the trial where available
    PL-MEOPA
    A.4.1Sponsor's protocol code numberRBHP_2014_CLAVELOU_2
    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 SponsorCHU de Clermont-Ferrand
    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 supportCHU de Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU
    B.5.2Functional name of contact pointDirection de la recherche clinique
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0473751195
    B.5.5Fax number0473754730
    B.5.6E-mailplacarin@chu-clermontferrand.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 Kalinox
    D.2.1.1.2Name of the Marketing Authorisation holderAIR LIQUIDE SANTE INTERNATIONAL
    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.3.4Pharmaceutical form Inhalation solution
    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.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients nécessitant la réalisation d'une ponction lombaire à visée diagnostique
    E.1.1.1Medical condition in easily understood language
    patients nécessitant la réalisation d'une ponction lombaire à visée diagnostique
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Evaluer l’efficacité antalgique du MEOPA durant la réalisation d’une ponction lombaire, en comparaison à un placebo.
    E.2.2Secondary objectives of the trial
    - Evaluer l’anxiolyse permise par l’utilisation de MEOPA durant la réalisation d’une ponction lombaire.
    - Rechercher des corrélations entre douleur, anxiété per-procédurale et anxiété générale évaluée par l’HAD (Hospital Anxiety and Depression) et le STAI (State Trait Anxiety Inventory).
    - Répertorier les effets indésirables liés à l’inhalation de MEOPA lors d’une ponction lombaire.
    - Evaluer le pourcentage de patients qui seraient prêts à avoir une autre ponction lombaire dans les mêmes conditions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients hospitalisés dans le service de neurologie pour la réalisation d’une ponction lombaire à visée diagnostique .
    - Age compris entre 18 et 60 ans.
    - Patients naïfs de MEOPA.
    - Signature du consentement éclairé écrit
    E.4Principal exclusion criteria
    - Contre-indication à l’utilisation de MEOPA :
    Nécessité de ventilation en oxygène pur
    Hypertension intra-crânienne
    Altération de la conscience empêchant la coopération du patient
    Traumatisme crânien
    Pneumothorax ou bulles d’emphysème
    Embolie gazeuse
    Distension gazeuse abdominale
    Patient ayant reçu un gaz ophtalmique dans les 3 mois précédents
    Carence en vitamine B12 non substituée
    Anomalies neurologiques d’apparition récente et non expliquées
    - Phobie du masque
    - Obésité morbide (IMC>35)
    - Trouble cognitif avec MMS <26/30
    - Utilisation préalable de MEOPA (à usage thérapeutique ou lors d’usage détourné récréatif)
    - Fièvre
    - Syndrome méningé
    - Confusion
    - Troubles de la communication verbale
    - participation simultanée à une autre recherche biomédicale pouvant interférer avec les objectifs de l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Echelle Numérique Simple de la douleur maximale ressentie durant la ponction lombaire recueillie dès la fin de la procédure
    E.5.1.1Timepoint(s) of evaluation of this end point
    à la fin de la ponction lombaire
    E.5.2Secondary end point(s)
    - Echelle Numérique Simple de l’anxiété maximale ressentie durant la ponction lombaire recueillie dès la fin de la procédure
    - Anxiété évaluée par les questionnaires: The Hospital Anxiety and Depression (HAD) (Zigmond and Snaith, 1983) et State Trait Anxiety Inventory (STAI) (Spielberger et al., 1983)
    - Proportion de patients présentant des effets indésirables éventuels : nausées, vertiges, sédation, euphorie, céphalées, autre (présence et intensité faible, modérée ou forte).
    - Durée de la ponction (temps durant lequel l’aiguille est en place)
    - Proportion de patients acceptant une nouvelle PL dans les mêmes conditions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    dès la fin de la ponction lombaire
    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 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
    A la fin de l'évaluation du dernierpatient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    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: 66
    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 Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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)
    Pas de modification de la prise en charge habituelle
    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 Decision2014-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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