Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43847   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-002571-33
    Sponsor's Protocol Code Number:49RC19_0106
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-04
    Trial results View 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 number2019-002571-33
    A.3Full title of the trial
    Transcutaneous measurement of oxygen during transient hyperoxia
    Mesure transcutanée de l’oxygène au cours de l’hyperoxie transitoire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Transcutaneous measurement of oxygen during transient hyperoxia
    Mesure transcutanée de l’oxygène au cours de l’hyperoxie transitoire
    A.3.2Name or abbreviated title of the trial where available
    SCHOTT
    A.4.1Sponsor's protocol code number49RC19_0106
    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 Angers
    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 Angers
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Angers
    B.5.2Functional name of contact pointBéatrice GABLE
    B.5.3 Address:
    B.5.3.1Street Address4 Rue Larrey
    B.5.3.2Town/ cityANGERS
    B.5.3.3Post code49933
    B.5.3.4CountryFrance
    B.5.4Telephone number33241356825
    B.5.5Fax number33241355968
    B.5.6E-mailbegable@chu-angers.fr
    D. IMP Identification
    D.IMP: 1
    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 Oxygène MESSERPHARMA
    D.2.1.1.2Name of the Marketing Authorisation holderMESSER France
    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 nameOxygène MESSERPHARMA
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Any patient with a cardiac output measurement
    Tout patient ayant une mesure du débit cardiaque
    E.1.1.1Medical condition in easily understood language
    Not applicable
    non applicable
    E.1.1.2Therapeutic area Not possible to specify
    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
    To evaluate the concordance between the simultaneous measurements of cardiac output measured by echocardiography-Transthoracic doppler or catheterization and response to transient inhalation of oxygen-enriched air in subjects with a cardiac output measurement in their management (assessment in the athlete or in the patient).
    Evaluer la concordance entre les mesures simultanées de débit cardiaque mesuré par échocardiographie-doppler transthoracique ou cathétérisme et la réponse à une inhalation transitoire d’air enrichi en oxygène chez des sujets ayant une mesure du débit cardiaque dans leur prise en charge (bilan chez le sportif ou chez le malade).
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults
    - Social security
    - written informed consent
    - cardiac output measurementscheduled within 2 hours
    -Sujets majeurs.
    -Sujets affiliés ou bénéficiaires d’un régime de sécurité sociale.
    -Sujets ayant signé un consentement éclairé au préalable.
    -Sujets dont une mesure du débit cardiaque est envisagée au moins 2 heures avant l’examen de l’étude, quelle qu’en soit la raison médicale.
    E.4Principal exclusion criteria
    - Refusal to consent
    - Adult patient protected under the law (guardianship)
    - Pregnancy or breast-feeding women
    - Patients unable to understand study procedures
    - Subjects suffering from acute or decompensated heart or respiratory failure.
    - Sujets ayant présenté des allergies aux adhésifs médicaux.
    - Sujets refusant de participer.
    - Sujets protégés au sens de la loi (femmes enceintes, parturientes et mères allaitantes ; personnes privées de liberté par une décision administrative ou judiciaire, personnes faisant l’objet de soins psychiatriques sous la contrainte ; mineurs ; personnes majeures faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer leur consentement).
    - Sujets inaptes à comprendre les objectifs ou consignes de l’étude.
    - Sujets souffrants d’insuffisance cardiaque ou respiratoire aigüe ou décompensée.
    E.5 End points
    E.5.1Primary end point(s)
    the temporal difference (mean phase shift) in observed responses from transcutaneous TcpO2 in the chest and periphery after two periods of inhalation of oxygen-enriched air (FiO2 ~ 60%) for 30 seconds separated by 5 minutes
    la différence temporelle (déphasage moyen) des réponses observées de la pO2 transcutanée en thoracique et en périphérie après deux périodes d’inhalation d’air enrichi en oxygène (FiO2 ~ 60%) pendant 30 secondes séparées de 5 minutes
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes
    30 minutes
    E.5.2Secondary end point(s)
    not applicable
    non applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    non applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    2 cardiac output measurement : echocardiography-Transthoracic doppler (routine care) and Tcp02
    E.8.2.4Number of treatment arms in the trial1
    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
    Last Visit of Last Subject
    Après l'inclusion du dernier patient
    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 months24
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state100
    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
    No
    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 Decision2019-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 17:08:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA