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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   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:2015-001835-20
    Sponsor's Protocol Code Number:OZBS12.15060
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-10-22
    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 number2015-001835-20
    A.3Full title of the trial
    Morphine intravenous vs. paracetamol intravenous after cardiac surgery in neonates and infants.
    Morfine IV vs. paracetamol IV na cardiochirurgie in neonaten en kinderen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Morphine or paracetamol as pain medication in children after open heart surgery
    Morfine of paracetamol als pijnstiller bij kinderen na open hart operaties.
    A.3.2Name or abbreviated title of the trial where available
    Morphine IV vs paracetamol IV for analgosedation in neonates and infants after cardiac surgery
    Morfine IV of paracetamol IV voor analgosedatie bij neonaten en kind na cardiochirurgie
    A.4.1Sponsor's protocol code numberOZBS12.15060
    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 SponsorErasmus MC
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointProject leader
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31107036189n.a.
    B.5.5Fax numbern.a.n.a.n.a.n.a.
    B.5.6E-maile.wildschut@erasmusmc.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 Morphine HCl 10 mg = 1 ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie
    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 nameMorfine HCl-3-water
    D.3.2Product code RVG 51950
    D.3.4Pharmaceutical form Solution for injection/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 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 Paracetamol 10 ml/ml solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    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 nameparacetamol
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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
    congenital cardiac defects
    Congenitale hartafwijkingen
    E.1.1.1Medical condition in easily understood language
    Congental cardiac defects
    Aangeboren hartafwijkingen
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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
    The primary outcome measure is the weight-adjusted cumulative morphine consumption (mcg/kg) in the first 48 hours post-operatively.
    Vermindering van de cumulatieve morfine behoefte in de eerste 48 uur na cardiochirurgie in mck/kg
    E.2.2Secondary objectives of the trial
    1. Incidence of adverse drug reactions
    a. hemodynamically: hypotension or bradycardia, with the need for intervention by means of medication or a fluid bolus.
    b. Decreased gastro-intestinal motility or intestinal obstruction not directly related to the underlying diagnosis and not previously existing, with the need for intervention.
    c. Vomiting.
    d. Number of re-intubations.
    e. Pediatric delirium as measured by the SOS-PD-scale.
    2. DNA analysis will be performed to evaluate the effect of gene polymorphisms on the PK of analgesic medication.
    3. Concomitant use of sedatives.
    4. The number of hours on ventilation.
    5. The length of PICU stay.
    6. To develop a population PKPD-based post-operative pain management algorithm based on the results of this trial.
    1. incidentie van ongewenste bijwerkingen
    a. hemodynamisch: hypotensie of bradycardie, met noodzaak tot interventie met medicatie of vocht bolus
    b. verminder gastro-intestinale motiliteit of obstructie,niet direct gerelateerd aan de onderliggende diagnose and niet eerder bestaand, met noodzaak tot interventie
    c. braken
    d. incidentie van re-intubatie
    e. delirium
    2. DNA analyse om gen polymorfismen te bepalendie invloed hebben op de PK van analgetica.
    3. gebruik van sedativa
    4. duur van ventilatie in uren
    5. ligduur op kinder IC
    6. resultaten van de trial worden gebruik om een PKPD-based pain protocol te maken
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent,
    Neonate / infant aged 0-36 months,
    Cardiac surgery with the use of CPB.
    Informed consent
    Neonaat of kind in de leeftijd van 0 t/m 36 maanden
    Cardiochirurgie met gebruik van de cardiopulmonale bypass
    E.4Principal exclusion criteria
    No informed consent
    Known allergy to or intolerance for paracetamol or morphine,
    Administration of opioids in the 24 hours prior to surgery.
    Hepatic dysfunction defined as three times the reference value of ALAT/ASAT.
    Renal insufficiency defined as Pediatric RIFLE category - injury, defined as estimated creatinine clearance reduced by 50% and urine output <0.5 ml/kg/h for 16 hours.
    Geen informed consent
    Bekende allergie tegen of intollerantie voor morfine of paracetamol
    toedienen van opioiden tot 24 uur voor de operatie
    leverfunctiestoornissen, gedefineerd als drie keer de referentiewaarden van ALAT/ASAT
    nierfunctiestoornissen, gedefineerd als 50% vermindering van klaring en urine output < 0.5 ml/kg/h gedurende 16 uur
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative morphine dose over 48 hours in mcg/kg.
    Cumulatieve morfine dosering gedurende 48 uur
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after surgery
    48 uur na einde van de operatie
    E.5.2Secondary end point(s)
    1. Level of pain assessed by validated PD instruments until 48 hours after stop study medication
    2. Incidence of adverse drug reactions
    3. Incidence of concomitant use of sedative
    4. Hours on ventilation
    5. Incidence of over- and undersedation
    6. Incidence of withdrawal syndrome and pediatric delirium
    7. The length of PICU stay
    8. Use of corticosteroids
    9. Parents postoperative pain measurement two days after discharge
    10. Bayley scales of infant and toddler development (one year after surgery)
    1. pijnscore tot 48 uur na stop studie medicatie
    2. incidentie van ongewenste bijwerkingen
    3. incidentie van gebruik van sedativa
    4. duur van ventilatie in uren
    5. incidentie van over- en ondersedatie
    6. incidentie van delier en onttrekkinsverschijnselen
    7. ligduur op kinder IC
    8. gebruik van corticosteroïden
    9. pijnmeting door ouders 2 dagen na ontslag uit ziekenhuis
    10. Bayley score voor ontwikkeling 1 jaar na operatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-8: 48 hours after stop study medication (96 hours after surgery)
    9: 2 days after discharge from hospital
    10: 1 year after surgery
    1 t/m 8: 48 uur na stoppen van de studiemedicatie (96 uur na de operatie)
    9: 2 dagen na ontslag uit het ziekenhuis
    10: 1 jaar na de operatie
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 concerned4
    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
    Insufficient effect of paracetamol as primary analgesic after cardiac surgery in children
    Onvoldoende effect van paracetamol as primair analgeticum na cardiochirurgie in kinderen
    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 Yes
    F.1.1Number of subjects for this age range: 208
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 50
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 58
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    children aged 0 - 36 months
    kinderen in de leeftijd van 0 t/m 36 maanden
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state208
    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
    Niet
    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 Decision2015-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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