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    Summary
    EudraCT Number:2016-002974-11
    Sponsor's Protocol Code Number:IBU24h-EchoG
    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:2016-09-26
    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 number2016-002974-11
    A.3Full title of the trial
    Phase III, randomized, multicenter, double-blind clinical trial to evaluate two echo-guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus: impact on intestinal prognosis
    Ensayo clínico fase III, aleatorizado, multicéntrico, doble ciego para evaluar dos pautas de administración del ibuprofeno en el tratamiento del ductus arterioso persistente eco-guiado: impacto en el pronóstico intestinal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the impact on the intestinal prognosis of 2 ibuprofen administration regimens for the treatment of patent ductus arteriosus, guided by echocardiography
    Ensayo clínico para evaluar el impacto en el pronóstico intestinal de 2 pautas de administración de ibuprofeno, para el tratamiento del ductus arterioso persistente, guiado por ecocardiografía
    A.4.1Sponsor's protocol code numberIBU24h-EchoG
    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 SponsorMaría Carmen Bravo Laguna
    B.1.3.4CountrySpain
    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 supportFundación Mutua Madrileña
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number003491 2071466
    B.5.5Fax number003491 2071466
    B.5.6E-mailherranz.estelles@gmail.com
    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 Pedea
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe Sar
    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 nameEcho-guided ibuprofen
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.3Other descriptive nameIbuprofeno
    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.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 Pedea
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe SAR
    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 nameECHO-GUIDED IBUPROFEN
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.3Other descriptive nameIBUPROFENO
    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
    patent ductus arteriosus
    ductus arterioso persistente
    E.1.1.1Medical condition in easily understood language
    patent ductus arteriosus
    ductus arterioso persistente
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10034130
    E.1.2Term Patent ductus arteriosus
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduce the incidence of NEC or AIP in preterm infants receiving treatment for closure of PDA with EchoG continuous IV infusion Iv EchoG IV. bolus of IB
    Disminuir la incidencia de ECN o PIA en los recién nacidos prematuros que reciben tratamiento para el cierre del DA con IB en perfusión iv continua y EchoG vs bolos iv y EchoG.
    E.2.2Secondary objectives of the trial
    Identify genetic polymorphisms in patients refractory to medical treatment of PDA and those most vulnerable to develop ECN or AIP.
    Exploratory Objectives: To evaluate the incidence of neonatal morbidity and mortality associated with each way of treatment
    Identificar polimorfismos genéticos en los pacientes refractarios a tratamiento médico del DA y en aquellos más vulnerables a presentar ECN o PIA.
    Objetivos exploratorios: Evaluar la incidencia de morbilidad y mortalidad neonatal asociada a cada una de las formas de tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Preterm infants less than 33 weeks gestational age
    2. PDA ≥ 1.5 mm and medical decision to start drug treatment
    3. Signed informed consent by the legal representative
    1. Recién nacidos prematuros con menos de 33 semanas de edad gestacional
    2. DA ≥ 1,5 mm con decisión de iniciar tratamiento farmacológico
    3. Consentimiento informado firmado por el representante legal
    E.4Principal exclusion criteria
    1. Consent Denied
    2. Presence of severe birth defects
    3. Congenital Heart Disease
    4. Contraindication for administration of IB:
    • oligoanuria (diuresis <1 cc / kg / h)
    • recent severe intraventricular bleeding (IVH grade III or extensive periventricular hemorrhagic infarction)
    • Serum creatinine> 1.5 mg / dl or clinical suspicion of intestinal ischemia.
    1. Consentimiento denegado
    2. Presencia de alteraciones congénitas graves
    3. Cardiopatías congénitas
    4. Contraindicación para la administración de IB:
    • Oligoanuria (diuresis < 1cc/kg/h),
    • Sangrado intraventricular reciente grave (HIV grado III o infarto hemorrágico periventricular extenso),
    • Creatinina sérica > 1,5 mg/dl o sospecha clínica de isquemia intestinal.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of NEC or API, defined as the presence of intestinal pneumatosis, pneumoperitoneum, or air in portal vein
    Incidencia de ECN o PIA, definida como la presencia de neumatosis intestinal, neumoperitoneo, o aire en vena porta
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time of discharge of Neonatology Department or at completed 40 weeks post-menstrual age (whichever comes first)
    Al alta del servicio de Neonatología o al haber cumplido 40 semanas de edad postmenstrual (lo que ocurra primero)
    E.5.2Secondary end point(s)
    • Perinatal endpoints:
    o Mother's age
    o gestational age
    o maternal medication (antibiotics, anticonvulsants, antihypertensives, drugs of abuse, heparin, tocolytic, etc)
    o Birthweight
    o Sex
    o weight (<P10)
    o prenatal corticosteroids (full cycle)
    o 5 minutes Apgar
    o amniorrhexis> 18 hours
    o Advanced Resuscitation at birth
    o SNAPPE II
    o clinical chorioamnionitis
    o histologically confirmed Chorioamnionitis
    o cord pH
    o Multiple Pregnancy
    o Need surfactant
    Age of onset or treatment
    • echocardiographic endpoints:
    o Prior to treatment:
     ductus size color Doppler supraesternal in a sagittal cut.
     Relationship AI / Ao (left atrium / aorta) in a long axis parasternal M-mode
     diastolic velocity in the left pulmonary branch with a sagittal parasternal.
     ratio E / A (wave left ventricular filling) with an apical 4-chamber window.
     scFv (superior vena cava flow) measuring the size from a half left parasternal and speed from a subcostal window.
     postductal diastolic velocity in aorta from supraesternal court.
    • cardiorespiratory endpoints:
    o Prior to each dose:
     Heart Rate
     Blood Pressure
     Respiratory rate
     ventilation mode
     PMVA (mean airway pressure)
     FiO2
     SatO2
     capillary pCO2
     arterial pCO2
     venous pCO2
     EB (Excess bases)
    Lactic acid 
     diuresis 24 hours before treatment
     Capillary refill
     Gradient center-peripheral Tª
     cardiovascular support prior to treatment (blood volume expanders in previous 24 hours, prior to each dose inotropic score of treatment = (dopamine x 1) + (dobutamine x 1) + (adrenaline x 10) or need for hydrocortisone.
    • Efficacy endpoints:
    o treatment failure, defined as the presence of ≥ 1.5 mm DA 24-48 hours after finishing a maximum of 6 doses of ibuprofen (2 full cycles).
    o number of doses administered ibuprofen.
    o closing rate after a treatment cycle
    o closing rate after two cycles of treatment.
    o time required until closing.
    o need for surgical ligation.
    o reopening rate: defined as the presence of ductal color Doppler flow after confirming previous close echocardiographic.
    • Genetic enpoints:
    o Study of genetic polymorphisms associated to therapeutic failure or risk of necrotizing enterocolitis or isolated intestinal perforation.
    o Study of genetic polymorphisms associated with the metabolism and elimination of ibuprofen and its relationship with the occurrence of adverse events.
    o Security Variables:
    o mortality before discharge from the neonatal unit
    o Days of income
    o Chronic Lung Disease (CLD), defined as the need for supplemental oxygen at 36 weeks post-menstrual age.
    o pulmonary hemorrhage diagnosed in the presence of fresh blood or discharge tinged with blood drawn from the endotracheal tube, associated with respiratory and radiological diagnosis deterioration or autopsy.
    o secondary pulmonary hypertension, in case the patient had an estimated ecocariografía ≥ 60% of systemic pressure after treatment with ibuprofen associated with respiratory impairment pulmonary pressure started.
    Time to reach or exclusive enteral nutrition.
    o gastrointestinal bleeding, if the presence of fresh blood in gastric aspiration remains collected by nasogastric tube during treatment with ibuprofen or bloody fluid.
    o oligoanuria defined as diuresis <1 cc / kg / h.
    Diagnosis of structural damage or central nervous system by USC at the age of the term.
    o drugs that the patient has received before and during treatment with ibuprofen
    • Variables perinatales:
    o Edad de la madre
    o Edad gestacional
    o Medicación materna (antibióticos, anticonvulsivantes, antihipertensivos, drogas de abuso, heparina, tocolíticos, etc)
    o Peso al nacer
    o Sexo
    o Peso (<P10)
    o Corticoides prenatales (ciclo completo)
    o Apgar 5 minutos
    o Amniorrexis > 18 horas
    o Reanimación avanzada al nacer
    o SNAPPE II
    o Corioamnionitis clínica
    o Corioamnionitis confirmada histológicamente
    o pH del cordón
    o Embarazo múltiple
    o Necesidad de surfactante
    o Edad de inicio de tratamiento
    • Variables ecocardiográficas:
    o Previo al tratamiento:
     Tamaño de ductus con Doppler color en un corte supraesternal sagital.
     Relación AI/Ao (aurícula izquierda/aorta) en un corte paraesternal eje largo en modo M.
     Velocidad diastólica en la rama pulmonar izquierda con un corte paraesternal sagital.
     Relación E/A (onda de llenado ventricular izquierdo) con una ventana apical 4 cámaras.
     FVCS (flujo en vena cava superior) midiendo el tamaño desde una ventana paraesternal izquierda media y la velocidad desde una ventana subcostal.
     Velocidad diastólica en aorta postductal desde un corte supraesternal.
    • Variables cardiorrespiratorias:
    o Previo a cada una de las dosis:
     Frecuencia cardiaca
     Presión arterial
     Frecuencia respiratoria
     Modalidad de asistencia respiratoria
     PMVA (presión media en vía aérea)
     FiO2
     SatO2
     pCO2 capilar
     pCO2 arterial
     pCO2 venosa
     EB (Exceso de bases)
     Ácido láctico
     Diuresis 24 horas previas al tratamiento
     Relleno capilar
     Gradiente de Tª central-periférico
     Soporte cardiovascular previo al tratamiento (expansores de volemia en 24 horas previas, el score inotrópico previo a cada dosis de tratamiento = (dopamina x 1) + (dobutamina x 1) + (adrenalina x 10) o necesidad de hidrocortisona.
    • Variables de evaluación de Eficacia:
    o Fracaso terapéutico, definido como la presencia de DA ≥ 1,5 mm 24-48 horas después de finalizar hasta un máximo de 6 dosis de ibuprofeno (2 ciclos completos).
    o Número de dosis de ibuprofeno administrados.
    o Tasa de cierre tras un ciclo de tratamiento
    o Tasa de cierre tras dos ciclos de tratamiento.
    o Tiempo necesario hasta el cierre.
    o Necesidad de ligadura quirúrgica.
    o Tasa de reapertura: definido como la presencia de flujo ductal por Doppler color tras haber confirmado cierre previo ecocardiográfico.
    • Variables Genéticas:
    o Estudio de polimorfismos genéticos asociados a fracaso terapéutico o riesgo de enterocolitis necrotizante o perforación intestinal aislada.
    o Estudio de polimorfismos genéticos asociados al metabolismo y eliminación del ibuprofeno y su relación con la aparición de acontecimientos adversos.
    o Variables de Seguridad:
    o Mortalidad antes del alta de la unidad de neonatología
    o Días de ingreso
    o Enfermedad Pulmonar Crónica (EPC), definida como la necesidad de oxígeno suplementario a las 36 semanas de edad postmenstrual.
    o Hemorragia pulmonar, diagnosticada ante la presencia de sangre fresca o secreción teñida de sangre extraída del tubo endotraqueal, asociado a deterioro respiratorio y radiológico o diagnóstico en autopsia.
    o Hipertensión pulmonar secundaria, en caso de que el paciente presentara una presión pulmonar estimada por ecocariografía ≥ 60% de la presión sistémica, una vez iniciado el tratamiento con ibuprofeno asociado a deterioro respiratorio.
    o Tiempo en alcanzar la nutrición enteral exclusiva.
    o Sangrado gastrointestinal, en caso de presencia de líquido sanguinolento o sangre fresca en los restos gástricos recogidos por aspiración de la sonda nasogástrica durante el tratamiento con ibuprofeno.
    o Oligoanuria, definida como diuresis < 1 cc/kg/h.
    o Diagnóstico de lesión estructural del sistema nervioso central por USC a la edad del término.
    o Fármacos que el paciente ha recibido antes y durante el tratamiento con ibuprofeno.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time of discharge of Neonatology Department or at completed 40 weeks post-menstrual age (whichever comes first)
    Al alta del servicio de Neonatología o al haber cumplido 40 semanas de edad postmenstrual (lo que ocurra primero)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Echo guided slow intravenous bolus of ibuprofen
    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 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
    last programmed visit of last enrolled subject
    última visita programada del último paciente incluido en el estudio
    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 months30
    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: 180
    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: 180
    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 No
    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 newborn infants
    Recién nacidos pretérmino
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    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 Decision2016-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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