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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   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).
     
    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:2012-005812-24
    Sponsor's Protocol Code Number:MalinJonssonFagerlund10
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-005812-24
    A.3Full title of the trial
    Acute ventilatory response to hypoxia during sedation with dexmedetomidine compared to propofol in healthy volunteers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the breathing response during reduced oxygen tension and simultaneous infusion of dexmedetomidine compared to propofol, two sedating agents.
    A.4.1Sponsor's protocol code numberMalinJonssonFagerlund10
    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 SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    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 supportKarolinska Institutet and Karolinska University Hospital, Solna
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressDept of Anesthesia and Intensive Care, Karolinska University Hospital, Solna
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number460851772066
    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 AuthorisationFinland
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.3Other descriptive namedexmedetomidine
    D.3.9.4EV Substance CodeSUB07037MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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.IMP: 2
    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 Propofol-Lipuro
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePropofol-Lipuro
    D.3.4Pharmaceutical form Emulsion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpropofol
    D.3.9.1CAS number 2078-54-8
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to 10
    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
    Healthy volunteers and the acute hypoxic ventilatory response during sedation with dexmedetomidine compared to propofol.
    Friska försökspersoner och effekt på det akuta hypoxiska ventilatoriska svaret vid sedering med dexmedetomidin jämfört med propofol.
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers and the breathing response to inspiration of a low fraction of oxygen during sedation with dexmedetomidine compared to propofol.
    Friska försökspersoner och andningssvar vid låg syrgashalt under sedering med dexmedetomidin jämfört med propofol, två olika lugnande läkemedel.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068084
    E.1.2Term Anesthesia procedure
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10062825
    E.1.2Term Monitored anaesthesia care sedation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Does dexmedetomidine affect the acute hypoxic ventilatory response in healthy volunteers? 2. Is the acute hypoxic ventilatory response in healthy volunteers less affected with dexmedetomidine than propofol at the same level of sedation?
    1. Påverkar dexmedetomidin det hypoxiska ventilatoriska svaret hos friska försökspersoner? 2. Påverkar dexmedetomidin det hypoxiska ventilatoriska svaret mindre än propofol vid motsvarande sederingsnivå hos friska försökspersoner?
    E.2.2Secondary objectives of the trial
    1. Does dexmedetomidine affect the acute hypercapnic ventilatory response in healthy volunteers?
    2. Is the acute hypercapnic ventilatory response in healthy volunteers less affected dexmedetomidine than propofol at the same level of sedation?
    3. Are there signs of an obstructed airway during sedation with dexmedetomidine or propofol?
    4. How does the plasma concentration of dexmedetomidine and propofol correlate to the level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S) and Richmond Agitation Sedation Score (RASS)?
    5. How does the level of sedation according to (OAA/S) correlate to (RASS) during dexmedetomidine and propofol infusion?
    6. Does the level of sedation according to OAA/S and RASS correlate to BIS during sedation with dexmedetomidine and propofol?
    1. Påverkar dexmedetomidin hyperkapnisk ventilatorisk respons (HCVR) hos friska försökspersoner?
    2. Påverkar dexmedetomidin hyperkapnisk ventilatorisk respons (HCVR) mindre än propofol vid motsvarande sederingsnivå?
    3. Ser man tecken till obstruerad övre luftväg vid sedering med dexmedetomidin eller propofol?
    4. Hur relaterar plasmakoncentration till grad av sedering med dexmedetomidin och propofol mätt med Observer´s Assessment of Alertness/Sedation Scale (OAA/S) och Richmond Agitation Sedation Score (RASS)?
    5. Hur väl korrelerar OAA/S med RASS vid sedering med dexmedetomedin och propofol?
    6. Hur väl korrelerar OAA/S och RASS med bispektral index (BIS) vid sedering med dexmedetomedin och propofol?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy male volunteers 18-40 years of age. No allergy or medication. Non-smokers, non-tobacco user. Normal weight, that is BMI<26.
    Helt friska män 18-40 år utan allergier eller medicinering. Icke-rökare/snusare. Normal vikt, dvs BMI<26.
    E.4Principal exclusion criteria
    Those who do not fulfill the inclusion criteria. Snoring during sleep. A beard or anatomy that unables the breathing mask to fit tightly.
    De som inte uppfyller inklusions-kriterierna. Känd snarkning. Skägg som omöjliggör att andningsmasken sluter tätt.
    E.5 End points
    E.5.1Primary end point(s)
    Hypoxic ventilatory response. That is the change of minute ventilation (VE) divided by the change in saturation (SpO2).
    Hypoxiskt ventilatoriskt svar, dvs den förändrade minutvolymen (VE) dividerat med förändrad saturation (SpO2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    When the second breathing test is done and the acute hypoxic ventilatory response has been measured during infusion of dexmedetomidine to achieve a moderate level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S).
    När det andra andningstestet har genomförts i studien och hypoxisk ventilatorisk respons har kontrollerats under infusion dexmedetomidin till moderat sederingsnivå enligt Observer´s Assessment of Alertness/Sedation Scale (OAA/S).
    E.5.2Secondary end point(s)
    Hypercapnic ventilatory respons. Respiratory rate. Tidal volume. Airway flow. Thoracic and abdominal impedance. Oxygen saturation. Level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S), Richmond Agitation Sedation Score (RASS) and bispectral index (BIS). Plasma concentration of dexmedetomidine and propofol.
    Hyperkapnisk ventilatorisk respons. Andningsfrekvens. Tidalvolymer. Andningsflöde. Buk och thoraximpedans. Syrgassaturation. Sederingsnivå skattad enligt Observer´s Assessment of Alertness/Sedation Scale (OAA/S), Richmond Agitation Sedation Score (RASS) och bispektral index (BIS). Plasma koncentration av dexmedetomidin och propofol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    When the second breathing test is done and the acute hypercapnic ventilatory response has been measured during infusion of dexmedetomidine to achieve a moderate level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S).
    När det andra andningstestet har genomförts i studien och hyperkapnisk ventilatorisk respons har kontrollerats under infusion dexmedetomidin till moderat sederingsnivå enligt Observer´s Assessment of Alertness/Sedation Scale (OAA/S).
    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 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 Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Försökspersonerna är sina egna kontroller. Försöket börjar med en undersökning utan läkemedel.
    The volunteers are their own comparator. The investigation will also be done without the drug.
    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 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
    LVLS
    Studien är slutförd när samtliga försökspersoner har genomfört andningstest efter utsatt infusion dexmedetomidin eller propofol, dvs efter undersökningsdag nummer två.
    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: 21
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 21
    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
    Inga
    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 Decision2013-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-16
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA