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    Summary
    EudraCT Number:2017-001612-11
    Sponsor's Protocol Code Number:3005032
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-001612-11
    A.3Full title of the trial
    A COMPARISON OF DEXMEDETOMIDINE VS PLACEBO AFFECT ON SLEEP-QUALLITY IN MECHANICAL VENTILATED CRITICAL ILL PATIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of dexmedetomidine vs placebo effect on sleep-quality in mechanical ventilated critical ill patients

    En sammenligning af dexmedetomidin vs placebo-effekt på søvnkvalitet hos 'mekanisk ventilerede kritiske syge patienter
    A.4.1Sponsor's protocol code number3005032
    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 SponsorRegion Hovedstaden
    B.1.3.4CountryDenmark
    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 supportOrion Pharma
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Hovedstaden
    B.5.2Functional name of contact pointPoul Jennum
    B.5.3 Address:
    B.5.3.1Street AddressNordre Ringvej 57
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538632512
    B.5.6E-mailpoul.jennum@regionh.dk
    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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameDexdor
    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 hydrochloride
    D.3.9.1CAS number 145108-58-3
    D.3.9.3Other descriptive nameDEXMEDETOMIDINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20317
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sleeping problems in mechanical ventilated critical ill patients in ICU
    Soevnloeshed i mekanisk ventilerede patienter
    E.1.1.1Medical condition in easily understood language
    Sleep problem in mechanical ventilated critical ill patients in ICU
    soevnloeshed
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10053319
    E.1.2Term Sleep study
    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
    Does dexmedetomidine improve deep sleep/sleep quality compared to placebo.
    Er dexmedetomidin forbedring dyb søvn / søvnkvalitet Sammenlignet med placebo.
    E.2.2Secondary objectives of the trial
    Does dexmedetomidine compared with placebo affect on
    a) sleep phases,
    b) daytime function, including anxiety and delirium,

    Er dexmedetomidin Sammenlignet med placebo-effekt på
    a) søvn faser,
    b) dagtimerne funktion, herunder angst og delirium,
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Admitted to an ICU
    • ≥ 18 years
    • Anticipated stay in the ICU for another day after sleep recording including patients in mechanically ventilated
    •Hemodynamically stable
    •Concious non sedated patients with Danish language
    en Møderet for ICU
    • ≥ 18 år
    Forventet ophold på intensivafdelingen til en anden dag, efter at sove optagelse herunder patient i mekanisk ventilerede
    • hæmodynamisk stabile
    • Conscious ikke bedøvet patient med dansk sprog
    E.4Principal exclusion criteria
    • Patients who are awake and conscious with a SOFA score over 12
    • Post operative patients
    • Trauma patients
    • Structual neurologic diseases (e.g. stroke, tumor), degenerative (e.g.Parkinsons disease, dementias), seizure, infectios or other disorders affecting the brain based on critical history of epilepsi
    • Major psychiatric disorder: schizophrenia, severe depression
    • Second or third degree atrionventricular block (unless pacemaker inplanted)
    • Positive pregnancy test or currently lactating/ known pregnancy or lactation
    • Severe agitated delirium at the time of inclusion
    • High risk of death in the study period due to concomitant disease.
    • Use of other alpha-2 agonists (clonidine) during ICU stay
    • Patients with limitations in therapy
    • Participation in other study involving use of a pharmacologically active compound
    • Otherwise unable to fulfill the study, according to investigator´s opinion.
    Patienter, som er vågen og bevidst med en sofa score over 12 og under klinisk relativt stabile.
    • Postoperativ patient
    • Trauma patient
    • Strukturpolitik neurologiske sygdomme (fx slagtilfælde, tumor), degenerativ (e.g.Parkinsons sygdom, demens), beslaglæggelse eller andre lidelser infectios påvirker hjernen baseret på kritisk epilepsi
    • Større psykiatrisk lidelse: skizofreni, svær depression
    • anden eller tredje grad atrionventricular blokke (medmindre pacemaker inplanted)
    • Positiv graviditetstest eller ammende øjeblikket / kendt graviditet eller amning
    • Svær ophidset delirium på tidspunktet for inklusion
    • Høj risiko for død i undersøgelsen periode på grund af samtidig sygdom.
    • Brug af andre alfa-2-agonister (clonidin) Under intensivafdeling
    • Patienter med begrænsninger i terapi
    • Deltagelse i andre undersøgelse med brug af en farmakologisk aktiv forbindelse
    • Ellers kan ikke opfylde undersøgelsen, ifølge Investigator udtalelse.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of deep sleep/sleep quality of clinical significance will be determined by slow wave activities using PolySomnoGraphy (PSG)
    Forbedring af dyb søvn / søvn kvaliteten af klinisk betydning vil blive bestemt af de langsomme bølge aktiviteter ved hjælp polysomnografi (PSG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continues measurement of sleep deept with a PolySomnoGraphy (PSG) during the study
    Fortsætter måling af søvndeept med en PolySomnoGraphy under undersøgelsen
    E.5.2Secondary end point(s)
    d) Sleep phases will be determined by PSG
    e) Daytime function including anxiety and delirium determined by Cam ICU and alertness and wakeness determined by RASS

    Sleep faser vil blive bestemt af PSG
    e) Dagtimerne funktion, herunder angst og delirium bestemt af Cam ICU og årvågenhed og wakeness bestemt af RASS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continues measurement during the study
    Fortsæt målinger i løbet af undersøgelsen
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    LVLS
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-10-27. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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
    Ikke
    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 Decision2017-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
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