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    Summary
    EudraCT Number:2013-003547-39
    Sponsor's Protocol Code Number:46077
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003547-39
    A.3Full title of the trial
    Dexmedetomidine vs. clonidine in delirious intensive care patients: a randomised open-label trial
    Dexmedetomidine vs clonidine: effect op delirante intensive care patiënten; een gerandomiseerd, open-label onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the medications dexmedetomidine and clonidine on delirium (confused) patients of the intensive care unit.
    Het effect van de medicijnen dexmedetomidine en clonidine op deliurium (verwardheid) bij patiënten op de intensive care afdeling
    A.4.1Sponsor's protocol code number46077
    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 SponsorIsala Klinieken
    B.1.3.4CountryNetherlands
    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 supportIsala Klinieken
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIsala Klinieken / Isala Academie
    B.5.2Functional name of contact pointafd. wetenschappelijk onderzoek
    B.5.3 Address:
    B.5.3.1Street AddressDokter van Heesweg 2
    B.5.3.2Town/ cityZwolle
    B.5.3.3Post code8025 BT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31384247767
    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 (dexmedetomidine)
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Pharma 2012
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.11 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 Catapresan (clonidinehydrochloride)
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim bv
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.11 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
    (ICU- associated) Delirium
    (Intensive care gerelateerde) Delirium
    E.1.1.1Medical condition in easily understood language
    Confusion in intensive care patients
    Verwardheid bij patiënten op de intensive care
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10012226
    E.1.2Term Delirium, cause unknown
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10071315
    E.1.2Term Mixed delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10071313
    E.1.2Term Hypoactive delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10071314
    E.1.2Term Hyperactive delirium
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10012220
    E.1.2Term Delirium due to a general medical condition
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The effects of sedation with clonidine or dexmedetomidine on the duration of haloperidol-resistent delirium in intensive care patients
    Het effect van sedatie met clonidine of dexmedetomidine op de duur van een haloperidol-resistent delirium bij patiënten van de intensive care afdeling
    E.2.2Secondary objectives of the trial
    The effect of treatment with clonidine or dexmedetomidine on
    1. the duration till extubation in case patients are mechanical ventilated
    2. the duration till discharge of the ICU
    3. the duration till reaching the aiming level of sedation (RASS0)
    4. insight in cost-effectiveness of the medications.
    Het effect van behandeling met clonidine of dexmedetomidine op:
    1. de tijd die nodig is tot detubatie indien de patiënt wordt beademd
    2. de tijd die nodig is tot ontslag van intensive care
    3. de tijd die nodig is tot het bereiken van het gewenste sedatieniveau (RASS 0)
    4. inschatting van de kosteneffectiviteit van beide middelen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age > 18
    - no response on treatment with haloperidol (max. dose till 3x5mg)
    - positive score CAM-ICU
    - leeftijd >18 jaar
    - onvoldoende effect van de behandeling met haloperidol (max. dosering tot 3x5mg)
    - positieve CAM-ICU score
    E.4Principal exclusion criteria
    - history of epilepsy, Parkinson's disease, hypokinetic rigid syndrome, or Lewy body dementia
    - treatment with antipsychotic drugs
    - pregnancy or breastfeeding
    - CVA < 6months
    - hypotension (< 90mmHg)
    - bradycardia (<50/min)
    - MAP < 60mmHg
    - comatose patients (RASS -4 or -5)
    - recent myocardial infarction of severe coronal insufficiency
    - 2nd of 3rd degree AV-block or sicksinussyndrome
    - known allergic reaction on clonidine of dexmedetomidine
    - voorgeschiedenis van epilepsie, Parkinson, hypokinetic rigid syndrome, of Lewy body dementia
    - patiënten die behandeld worden met andere anti-psychotica
    - zwangerschap of borstvoeding
    - CVA < 6mnd geleden
    - hypotensie (<90mmHg)
    - bradycardie (< 50/min)
    - MAP < 60mmHg
    - comateuze patiënt (RASS -4 of -5)
    - recent myocard infarct of bekend met ernstige coronaire insufficiëntie
    - 2e of 3e graads AV-blok of het sick-sinussyndroom
    - bekende allergie op clonidine of dexmedetomidine
    E.5 End points
    E.5.1Primary end point(s)
    Total number of treatment hours with the alpha2-agonist untill a negative CAM-ICU score for three successive days.
    Het totaal aantal uur behandeling met de alfa2-agonist totdat er een negatieve score van de CAM-ICU is bereikt voor drie opeenvolgende dagen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 weeks
    Na 12 weken
    E.5.2Secondary end point(s)
    - RASS score while treated with the alpha2-agonist
    - total number of days till extubation after start alpha2-agonist (in case the patients are mechanical ventilated)
    - total number of days till discharge intensive care unit
    - RASS score tijdens behandeling met de alfa2-agonist
    - aantal dagen tot detubatie, in het geval dat de patiënt beademd wordt.
    - aantal dagen tot ontslag van de intensive care afdeling
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 12 weeks
    Na 12 weken
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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
    The total duration of the trial is 12 weeks. Patients who are randomized in these 12 weeks are included. If a patient is included on the last day of this 12 weeks through randomization, the studyresults will be used in analyses
    De totale duur van het onderzoek is 12 weken. Patiënten die in deze 12 weken zijn gerandomiseerd, zijn geïncludeerd. Wanneer een patiënt op de laatste dag van deze 12 weken wordt geïncludeerd door randomisatie, zullen deze onderzoeksresultaten nog worden gebruikt in de analyse van het onderzoek.
    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 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: 10
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In case of a delirium, the patient is in no condition to make justified decisions about their health, so they cannot give consent.
    Wanneer er sprake is van een delirium, is een patiënt niet in staat om goede beslissingen te nemen over zijn gezondheid, en kan geen toestemming gevraagd worden aan deze patiënt.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    Geen
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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