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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2011-004762-15
    Sponsor's Protocol Code Number:VUMC38027
    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:2012-05-07
    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 number2011-004762-15
    A.3Full title of the trial
    Early pharmacological intervention to prevent delirium: HAlopeRidol PrOphylaxis in Older emergency department patieNts.
    The HARPOON study
    Preventie van delirium door vroegtijdige pharmacologische interventie: haloperidol profylaxe bij acuut opgenomen oudere patiënten. De 'HARPOON' studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early treatment with haloperiodl to prevent acute confusion in older patients who are acutely admitted to the hospital.
    Vroegtijdige behandeling met het medicijn haloperidol om plotseling verwardheid te voorkomen bij oudere patiënten die acuut worden opgenomen in het ziekenhuis.
    A.3.2Name or abbreviated title of the trial where available
    Haloperidol prophylaxis in older acutely admitted patients
    Haloperidol profylaxe in acuut opgenomen oudere patiënten.
    A.4.1Sponsor's protocol code numberVUMC38027
    A.5.4Other Identifiers
    Name:Netherlands Trial RegisterNumber:3207
    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 SponsorVU Univeristy Medical Centre
    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 supportVU Univeristy Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Centre
    B.5.2Functional name of contact pointICAR-VU
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 7057
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1007 MB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204448111
    B.5.5Fax number0031204448255
    B.5.6E-mailicar@vumc.nl
    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 Haloperidol
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm Etten-leur The Netherlands
    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.3.1Product nameHaloperidol
    D.3.2Product code RVG 55776
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaloperidol
    D.3.9.1CAS number 52-86-8
    D.3.9.2Current sponsor codeRVG 55776
    D.3.9.3Other descriptive nameHALOPERIDOL
    D.3.9.4EV Substance CodeSUB08005MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Delirium
    Delirium
    E.1.1.1Medical condition in easily understood language
    Delirium is an acute and severe confusional state, and a reaction of the brain to an underlying cause (mostly physical disease).
    Delirium ('delier') is een plotseling optredende, ernstige verwardheid, als reactie van de hersenen op een onderliggend probleem (vaak een lichamelijke ziekte).
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 effect of early haloperidol prophylaxis (1mg twice-daily) on the incidence, severity and duration of in-hospital delirium in at-risk patients aged 70 years or over who are admitted to the hospital through the ED, to an acute admission facility, general internal medicine or surgical ward.
    Wat is het effect van vroege prophylaxis met een lage dosering haloperidol (1mg tweemaal daags) op de incidentie, duur en ernst van delirium in risico-patiënten ouder dan 70 jaar die via de spoedeisende hulp worden opgenomen in het ziekenhuis voor de acute opname afdeling, algemene interne geneeskunde of chirurgie?
    E.2.2Secondary objectives of the trial
    To determine:
    - mean hospital length of stay (LOS);
    - in-hospital and 6-month mortality rate;
    - (I)ADL and cognitive (6-item CIT) function at baseline, and at 3- and 6-months after hospital discharge;
    - the need for additional (medical) care after hospital discharge or institutionalization;
    - the cost-effectiveness;
    And to additionally describe any differences in the abovementioned secondary objectives between both intervention groups.
    Het beschrijven van onderstaande eindpunten en verschillen daarin tussen beide interventie groepen.
    - gemiddelde ziekenhuis opname duur;
    - mortaliteit gedurende ziekenhuisopname en 6 maanden na ontslag;
    - functionaliteit (lichamelijk en cognitief) en onafhankelijkheid bij opname, 3 en 6 maanden na ontslag uit het ziekenhuis;
    - wordt er na ontslag uit het ziekenhuis gebruik wordt gemaakt van aanvullende (medische) (thuis) zorg of opname in een zorg/revalidatie instelling;
    - kosteneffectiviteit t.a.v. bovenstaande.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 70 years or over;
    - The patient is at increased risk for developing in-hospital delirium on admission according to one or more positive answers on the VMS delirium-risk questions;
    - The patient or proxy is able to provide written informed consent;
    - The patient or proxy speaks either Dutch or English;
    - The patient is admitted to the hospital for an internal or surgical specialty.
    - Patient leeftijd ≥ 70 jaar
    - Patient heeft een verhoogd risico op het ontwikkelen van delier bij opname volgens de VMS delier risico vragen (één of meer van de 3 vragen positieve beantwoord)
    - Patient of wettelijke vertegenwoordiger kan informed consent geven
    - Patient of wettelijke vertegenwoordiger spreekt Nederlands of Engels
    - Patient wordt opgenomen voor interne geneeskunde of chirurgisch specialisme
    E.4Principal exclusion criteria
    - Patients presenting in the ED with delirium according to the DSM-IV criteria;
    - Patients with clinically significant (cardiac) disorders: QTc interval prolongation (QTc ≥ 500ms), recent acute myocardial infarction, uncompensated heart failure (working diagnosis), acute coronary syndrome (ACS), arrhythmias treated with class IA and III antiarrhythmic medicinal products, history of ventricular arrhythmia, history of torsade de pointes, clinically significant bradycardia, second or third degree heart block, uncorrected hypokalaemia (potassium level 3.0 or lower);
    - Patients with vascular dementia;
    - Patients with Lewy Body dementia;
    - Patients with Parkinson (dementia);
    - Patients with (a history of) hypokinetic movement disorders;
    - Patients with (a history of) malignant neuroleptic syndrome;
    - Patients with (a history of) serotonergic syndrome;
    - Patients with (a history of) central anticholinergic syndrome;
    - Patients who will be admitted to the oncology ward;
    - Patients who have been previously enrolled in the HARPOON study, or who are currently enrolled in other medical- or drug (intervention) studies;
    - Patients using medications of which concomitant use with haloperidol and/or use during the 7-day intervention period according to protocol (SOP comedication) is contraindicated. Patients using QTc prolonging drugs at presentation with QTc ≤450ms (men) / QTc ≤460ms (women) on baseline ECG may be included in the study with repetitive ECG control according to protocol;
    - Epilepsy
    - Substance abuse and dependence (DSM-IV criteria);
    - Patients who are not able to take study medication according to the protocol.
    - Patient met delier (volgens DSM-IV criteria) bij presentatie op de spoedeisende hulp
    - Patient presenteert zich op de spoedeisende hulp met klinisch significante (cardiale) problematiek: verlengde QTc ≥500ms, recent acuut myocardinfarct, niet-gecompenseerd hartfalen (werkdiagnose), acuut coronair syndroom (ACS), aritmieën behandeld met klasse IA en III anti-arritmica, ventricualire artimieën, torsade de pointes in de voorgeschiedenis, klinisch significante bradycardie, 2e of 3e graads blok op ECG, ongecorrigeerde hypokaliëmie (kalium 3.0 of lager);
    - Patient met vasculaire dementie, Lewy Body dementie of Parkinson (dementie);
    - Patient met een hypokinetische bewegingsstoornis (in de voorgeschiedenis);
    - Patient is bekend met een maligne neuroleptica syndroom (in de voorgeschiedenis);
    - Patient met een serotonerg syndroom (in de voorgeschiedenis);
    - Patient met een anticholinerg syndroom (in de voorgeschiedenis);
    - Patient wordt opgenomen op de oncologie afdeling;
    - Patient heeft eerder meegedaan in de HARPOON studie of doet mee in een andere (klinische) (interventie) studie;
    - Patienten die medicatie gebruiken waarvan gelijktijdig gebruik met haloperidol en/of gedurende de 7 dagen interventie studieperiode volgens de SOP comedicatie is gecontraindiceerd. (Patiënten die gelijktijdig QTc verlengende middelen gebruiken mogen wel geïncludeerd worden indien QTc ≤450ms (man) / QTc ≤460ms (vrouw) op baseline ECG, onder herhaaldelijke ECG controle volgens protocol);
    - Epilepsie;
    - Middelenmisbruik en afhankelijkheid (DSM-IV criteria);
    - Patiënten die niet in staat zijn om de studiemedicatie volgens het protocol in te nemen.
    E.5 End points
    E.5.1Primary end point(s)
    An absolute reduction of delirium incidence of 10%.
    An absolute reduction of delirium duration.
    Less severe delirium in haloperidol intervention group.
    Een absolute mindering van delirium incidentie van 10%.
    Een absolute mindering van de duur van delirium.
    Minder ernstig delirium in haloperidol groep.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 30 days from admission, or sooner when patients is discharged home previously.
    30 dagen na ziekenhuisopname, of eerder als de patiënt eerder wordt ontslagen.
    E.5.2Secondary end point(s)
    A reduction of mean hospital length of stay.
    A reduction in 6-month mortality.
    Functionality at baseline and change in functionality at 3- and 6 months.
    Need for additional (helath)care and/or institutionalisation.
    Een mindering van de gemiddelde ziekenhuisopname duur.
    Een mindering van de 6-maanden mortaliteit.
    Functionaliteit at baseline en de verandering in functionaliteit op 3- en 6 maanden.
    Gebruik van aanvullende zorg en/of opname in verpleeghuis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 days from admission, or sooner when patients is discharged home previously.
    At respectively 90- and 180 days from hospital discharge date (time points: 3- and 6 months).
    30 dagen na ziekenhuisopname, of eerder als de patiënt eerder wordt ontslagen.
    Na respectievelijk 90 en 180 dagen vanaf onstalg uit het ziekenhuis (time points: 3 en 6 maanden).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    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 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) Yes
    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 concerned3
    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 end of the study is defined as the date of database disclosure, after the last patient has been contacted for the 6-month follow up data collection.
    Einde van de studie is wanneer de data base gesloten wordt, dus nadat data verzameld is van de laatste patiënt op time point 6 maanden.
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    We will include patients admitted through the emergency department. Due to specific (disease) related issues, the patients might not be capable of giving informed consent. Informed consent from an independent witness/proxy will then be obtained.
    Wij includeren patiënten opgenomen via de spoedeisende hulp. Als door ziekte of bepaalde omstandigheden de patiënt niet in staat is informed consent te geven, zal de wettelijk vertegenwoordiger/onafhankelijek getuige om toestemming worden gevraagd.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state780
    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)
    Participation for a subject in the trial ends after the telephone contact with the investigator during the follow-up period at time point 6 months. Hereafter the patient will receive normal treatment and care according to their personal needs.
    Deelname voor een patient aan de studie eindigt na het laatste telefoongesprek op time point 6 maanden in de follow-up periode. Hierna zal de patient reguliere zorg ontvangen, afhankelijk van zijn of haar zorg behoefte(n).
    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 Decision2012-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
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