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    Summary
    EudraCT Number:2015-003177-14
    Sponsor's Protocol Code Number:IBUPAR-Trial
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003177-14
    A.3Full title of the trial
    Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
    Paracetamol versus Ibuprofeno en recién nacidos prematuros con diagnóstico de ductus arterioso persistente hemodinámicamente significativo: ensayo clínico aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
    Paracetamol versus Ibuprofeno en recién nacidos prematuros con diagnóstico de ductus arterioso persistente hemodinámicamente significativo: ensayo clínico aleatorizado.
    A.4.1Sponsor's protocol code numberIBUPAR-Trial
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for injection
    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 INNParacetamol
    D.3.9.1CAS number 103-90-2
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIbuprofen
    D.3.4Pharmaceutical form Solution for injection
    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 INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Persistent ductus arteriosus haemodynamically significant
    Ductus arterioso persistente hemodinamicamente significativo
    E.1.1.1Medical condition in easily understood language
    Persistent ductus arteriosus haemodynamically significant
    Ductus arterioso persistente hemodinamicamente significativo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 compare the efficacy of the standard treatment of PDA with ibuprofen versus paracetamol in closing the patent ductus arteriosus to determine its non-inferiority to ibuprofen.
    Comparar la eficacia del tratamiento estándar del PDA con ibuprofeno versus paracetamol en el cierre del ductus persistente para determinar su no inferioridad frente a ibuprofeno.
    E.2.2Secondary objectives of the trial
    1. To compare the safety of both treatments by the rate of early and late complications.
    2. Set the pharmacokinetics and pharmacodynamics of paracetamol in the neonatal period in infants with persistent ductus.
    3. Study of biomarkers and polymorphisms in urine
    1. Comparar la seguridad de ambos tratamientos mediante la tasa de complicaciones tempranas y tardías.
    2. Establecer la farmacocinética y farmacodinamia del paracetamol en el período neonatal en recién nacidos con ductus persistente.
    3. Estudio de biomarcadores y polimorfismos en orina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Informed consent signed by parents or legal representative.
    ? Gestational age ? 30 weeks.
    ? Postnatal age ? 2 weeks
    ? 1st episode of hemodynamically significant PDA diagnosed by ultrasound:
    1. Continuous flow through DAP.
    2. Retrograde diastolic flow in the descending aorta.
    3. Strain the left atrium. (relationship left atrium / aorta (LA / AO)> 1.5).
    4. Ductal diameter greater than 1.7 mm.
    5. Relationship ductus / descending aorta diameter size greater than 0.5.
    ? Need for ventilatory support
    ? Born in participating hospitals or coming to them in the application of the treatment period
    ? Consentimiento informado firmado por padres o representante legal.
    ? Edad gestacional ? 30 semanas.
    ? Edad postnatal ? 2 semanas
    ? 1º episodio de DAP hemodinámicamente significativo diagnosticado mediante ecografía:
    1. Flujo continuo a través de DAP.
    2. Flujo retrogrado diastólico en la aorta descendente.
    3. Distensión de la aurícula izquierda. (relación aurícula izquierda/ aorta (LA/AO) > 1.5).
    4. Diámetro ductal superior a 1.7 mm.
    5. Relación tamaño ductus/diámetro aorta descendente superior a 0.5.
    ? Necesidad de soporte ventilatorio
    ? Nacidos en hospitales participantes o llegada a los mismos dentro del periodo de aplicación del tratamiento
    E.4Principal exclusion criteria
    - Gestational age> 30 weeks
    - Postnatal age> 2 weeks
    - Major congenital malformations.
    - Impending doom.
    - Chromosomopaties.
    - Refusal to participate and / or sign the informed consent.
    - Inability to randomization or scrambling wrong.
    - Participation in another clinical trial
    - Diuresis less than 1 ml / kg / h for 8 h prior to treatment
    - Greater than 1.8 mg / dl Creatinine
    - Platelets below 50,000 / uL
    - Active bleeding (tracheal, gastrointestinal and renal)
    - Intraventricular hemorrhage recently (48h) (grades 3-4)
    - Severe hyperbilirubinemia
    - Liver failure or severe coagulopathy
    - Active necrotizing enterocolitis or intestinal perforation
    - Septic shock
    - Edad gestacional >30 semanas
    - Edad postnatal > 2 semanas
    - Malformaciones congénitas mayores.
    - Muerte inminente.
    - Cromosomopatías.
    - Rechazo a participar y/o firmar el consentimiento informado.
    - Imposibilidad de aleatorización o aleatorización errónea.
    - Participación en otro ensayo clínico
    - Diuresis inferior a 1 ml/kg/h en las 8 h previas al tratamiento
    - Creatinina superior a 1,8 mg/dl
    - Plaquetas inferiores a 50.000/?L
    - Hemorragia activa (traqueal, digestiva o renal)
    - Hemorragia intraventricular reciente (48h) (grados 3-4)
    - Hiperbilirrubinemia grave
    - Coagulopatía severa o fallo hepático
    - Enterocolitis necrotizante activa o perforación intestinal
    - Shock séptico
    E.5 End points
    E.5.1Primary end point(s)
    Non-inferiority incidence of PDA clousure (clousure rate 80%)
    No inferioridad en la tasa de cierre de DAP (tasa cierre 80%)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After a máximum of 6 doses of paracetamol
    Después de como máximo 6 dosis de paracetamol
    E.5.2Secondary end point(s)
    Security:
    1. Incidence of early complications: oliguria, renal failure, necrotizing enterocolitis, intraventricular hemorrhage, hyperbilirubinemia, gastrointestinal bleeding or perforation.
    2. Incidence of late complications: bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of the newborn, sepsis, death
    Pharmacokinetics:
    1. Determination of plasma levels of paracetamol
    2. Pharmacodynamics of paracetamol in the ductus. pharmacokinetic model
    3. Relationship plasma levels effectively / adverse reactions
    Biomarkers and polymorphisms
    1. Determination of biomarkers and polymorphisms in urine
    2. Relationship disposal / drug metabolism
    Seguridad:
    1. Incidencia de complicaciones tempranas: oliguria, fallo renal, enterocolitis necrosante, hemorragia intraventricular, hiperbilirrubinemia, sangrado o perforación gastrointestinal.
    2. Incidencia de complicaciones tardías: displasia broncopulmonar, leucomalacia periventricular, enterocolitis necrotizante, retinopatía del neonato, sepsis, muerte
    Farmacocinética y farmacodinamia:
    1. Determinación de los niveles plasmáticos de paracetamol
    2. Farmacodinamia del paracetamol en el ductus. Modelo farmacocinético
    3. Relación niveles plasmáticos con efectividad/reacciones adversas
    Biomarcadores y polimorfismos
    1. Determinación de biomarcadores y polimorfismos en orina
    2. Relación con eliminación/metabolización del fármaco
    E.5.2.1Timepoint(s) of evaluation of this end point
    Early complications: during treatment
    Late complications: until discharge
    Complicaciones precoces: durante el tratamiento
    Complicaciones tardías: hasta el alta hospitalaria
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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 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 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 years2
    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: 396
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 396
    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) 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
    Preterm babies
    Recién nacidos prematuros
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state396
    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
    Ninguno
    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 Decision2016-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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