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    Summary
    EudraCT Number:2009-010901-35
    Sponsor's Protocol Code Number:G83627057
    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:2009-12-01
    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 number2009-010901-35
    A.3Full title of the trial
    ESTUDIO ALEATORIZADO Y DOBLE CIEGO CON DOBUTAMINA VERSUS PLACEBO PARA EL TRATAMIENTO DEL BAJO FLUJO EN VENA CAVA SUPERIOR EN RECIÉN NACIDOS DE BAJO PESO: EVALUACIÓN SISTEMÁTICA DE LOS EFECTOS SOBRE LA HEMODINÁMICA CEREBRAL Y SISTÉMICA
    A.4.1Sponsor's protocol code numberG83627057
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación de Investigación Biomédica Hospital La Paz
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DOBUTAMINA MAYNE 12,5 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderMAYNE PHARMA ESPAÑA, S.L.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDOBUTAMINA
    D.3.9.1CAS number 34368-04-2
    D.3.9.3Other descriptive nameDOBUTAMINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    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
    BAJO FLUJO EN VENA CAVA SUPERIOR
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level HLGT
    E.1.2Classification code 10007539
    E.1.2Term Cardiac disorder signs and symptoms
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Conocer la prevalencia de bajo FVCS en nuestra población de riesgo
    2. Análisis sistemático del efecto sobre la circulación cerebral y sistémica del tratamiento precoz del bajo FVCS con DB en el prematuro más vulnerable.
    E.2.2Secondary objectives of the trial
    1. Abundar en el conocimiento de la respuesta individual al tratamiento (dosis-respuesta al fármaco)
    2. Evaluar los cambios en los patrones de oxigenación-perfusión cerebral con particular atención a la autorregulación del FSC, así como de la perfusión sistémica, durante la etapa de circulación transicional en dicha población, por medio de tecnología no invasiva
    3. Profundizar en el conocimiento de los mecanismos que producen lesión estructural cerebral en el prematuro
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Recién nacidos con edad gestacional &#8804; 28 semanas y
    2. Recién nacidos > 28 semanas y &#8804; 30 semanas de gestación con distrés respiratorio moderado-severo, definido como la necesidad de soporte respiratorio con una presión media en vía aérea &#8805; 4 cm H2O ó FiO2 &#8805; 0.3
    3. Ingreso <6 horas de vida en la Unidad de Cuidados Intensivos Neonatales (UCIN) del Hospital Universitario La Paz
    4. Consentimiento informado
    E.4Principal exclusion criteria
    1. Hipotensión arterial precoz, definida como un valor de presión arterial media (PAM) menor a la edad gestacional del paciente, mantenida al menos 60 minutos, y que no se corrige con una expansión de volemia
    2. Malformación congénita mayor que comprometa la vida del paciente
    3. Consentimiento denegado
    E.5 End points
    E.5.1Primary end point(s)
    • Variables de hemodinámica sistémica (ecocardiografía funcional en diferentes momentos, ver apartado 4.8):
    o Prevalencia de recién nacidos con bajo FVCS (<41cc/kg/min )
    o Dosis requerida para conseguir FVCS-OP (>40 cc/kg/min)
    o Dosis requerida para conseguir FVCS-OP-60 (>40 cc/kg/min mantenido durante 60 minutos)
    • Variables de oxigenación-perfusión cerebral: se monitorizarán de forma continua el TOI, &#8710;HbT, &#916;DHb mediante NIR-SRS. Además se medirán de forma intermitente los cambios en VFSC e IR en las arterias cerebrales. Se medirán los efectos que ejercen sobre las mismas los cambios del FVCS o los sucesivos incrementos en la dosificación (DB o PL) en diferentes momentos del estudio
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3Other No
    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 Information not present in EudraCT
    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
    Los pacientes serán evaluados en distintos momentos durante los 4 primeros días de vida. Se recogerán prospectivamente los datos obtenidos del programa de seguimiento neuroevolutivo que se lleva a cabo de forma rutinaria en la Unidad de Neonatología en esta población.
    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 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 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.3Newborns (0-27 days) Yes
    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
    RECIÉN NACIDOS PREMATUROS EN LAS PRIMERAS 12 HORAS DE VIDA
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    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 Decision2010-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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