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    Summary
    EudraCT Number:2012-005299-32
    Sponsor's Protocol Code Number:OPHT-110912
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-005299-32
    A.3Full title of the trial
    Effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MRI
    Die Auswirkung von 100% Sauerstoff Atmung auf Stoffwechselprodukte des Gehirns die mit dem 7-Tesla MRT gemessen werden.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MRI
    Die Auswirkung von 100% Sauerstoff Atmung auf Stoffwechselprodukte des Gehirns die mit dem 7-Tesla MRT gemessen werden.
    A.3.2Name or abbreviated title of the trial where available
    MR Hyperoxia
    A.4.1Sponsor's protocol code numberOPHT-110912
    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 SponsorMedizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien
    B.5.2Functional name of contact pointUniv. Klinik f. Klin. Pharmakologie
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404002981
    B.5.5Fax number+431404002998
    B.5.6E-mailklin-pharmakologie@meduniwien.ac.at
    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 Sauerstoff medizinisch Messer
    D.2.1.1.2Name of the Marketing Authorisation holderMesser Group GmbH, Gumpoldskirchen
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSauerstoff medizinisch Messer
    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.3.8INN - Proposed INNOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    brain metabolism
    Gehirn Metabolite
    E.1.1.1Medical condition in easily understood language
    brain metabolism
    Gehirn Metabolite
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033316
    E.1.2Term Oxygen saturation
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of breathing 100% oxygen on brain metabolites measured by 7-Tesla MR spectroscopy (MRS)
    Einfluss von 100% Sauerstoffatmung auf Metabolite des Gehirns, die mittels 7-Tesla MRT gemessen werden
    E.2.2Secondary objectives of the trial
    High energy phosphates
    Metabolites: glutamine, glutamate, GABA, tCr, NAA and choline
    Hochenergetische Phosphate
    Metabolite: Glutamin, Glutamat, GABA, tCr, NAA und Cholin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:

    - Men and women aged between 18 and 35 years
    - Non-smokers
    - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
    - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
    Einschlusskriterien:
    - Männer und Frauen zwischen 18 und 35 Jahren
    - Nichtraucher
    - Unauffällige Anamnese, außer der Untersucher erachtet eine Abweichung als nicht relevant
    - Normale Laborwerte ausser der Untersucher erachtet eine Abweichung als nicht relevant.
    E.4Principal exclusion criteria
    Exclusion criteria

    Any of the following will exclude a subject from the study:

    - Symptoms of a clinically relevant illness in the 3 weeks before the first study day
    - Presence or history of a severe medical condition as judged by the clinical investigator
    - Presence or history of arterial hypertension
    - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
    - Blood donation during the previous three weeks
    - Abnormalities in the 12-lead electrocardiogram

    Ausschlusskriterien:
    - Symptome einer klinisch relevanten Erkrankung in den letzten 3 Wochen vor dem Studientag
    - Vorgeschichte oder Vorhandensein einer schweren Erkrankung
    - Vorgeschichte oder Vorhandensein von arterieller Hypertension
    - Regelmäßige Einnahme von Medikamenten (ausser Kontrazeptiva)
    - Alkoholmissbrauch
    - Teilnahme an einer klinischen Studie innerhalb der letzten 3 Wochen vor der Studie
    - Blutspenden bis zu drei Wochen vor dem Studientag
    - Veränderungen im EKG
    - Vorliegen einer Schwangerschaft
    - Metallische Fremdkörper im oder am Körper die nicht entfernt werden können
    - Platzangst
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Wirksamkeit
    E.5.1.1Timepoint(s) of evaluation of this end point
    on study day
    am Studientag
    E.5.2Secondary end point(s)
    Tolerability
    Tolerabilität
    E.5.2.1Timepoint(s) of evaluation of this end point
    on study day
    am Studientag
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.1Randomised No
    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 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 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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    The study may be prematurely terminated if SAEs or other significant side effects occurs. If the subject wants to prematurely terminate the study by any reason.
    Beim Auftreten von SAEs oder signifikanten Nebenwirkungen im Zusammenhang mit der Studienmedikation wird die Studie vorzeitig beendet. Wenn der Studienteilnehmer die Studie vorzeitig, aus welchen Gründen auch immer, beenden will
    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 months0
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state15
    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)
    No treatment is planned after end of study
    Keine geplante Therapie nach Studienende
    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 Decision2013-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-08-03
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