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    Summary
    EudraCT Number:2014-001380-13
    Sponsor's Protocol Code Number:PROPADB-01
    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:2014-04-25
    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 number2014-001380-13
    A.3Full title of the trial
    Effects of the treatment with propranolol in the burnt adult intubated patient with sinusal tachycardia induced by burns.
    EFECTOS DEL TRATAMIENTO DE LA TAQUICARDIA SINUSAL INDUCIDA POR LA QUEMADURA EN EL PACIENTE QUEMADO CRÍTICO INTUBADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROPRANOLOL IN BURNT ADULT PATIENTS
    PROPANOLOL EN EL PACIENTE QUEMADO ADULTO
    A.3.2Name or abbreviated title of the trial where available
    PROPADB-01
    PROPADB-01
    A.4.1Sponsor's protocol code numberPROPADB-01
    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 SponsorAbelardo Garcia De Lorenzo / Teresa Nuñez-Villaveiran
    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 supportnone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeresa Nuñez-Villaveiran
    B.5.2Functional name of contact pointTeresa
    B.5.3 Address:
    B.5.3.1Street AddressPaseo Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917277211
    B.5.6E-mailtnuvi@hotmail.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 SUMIAL
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio Icaro S.A
    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 namePROPRANOLOL
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPRANOLOL HIDROCLORURO
    D.3.9.1CAS number 525-66-6
    D.3.9.4EV Substance CodeSUB10119MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    BURNT-INDUCED SINUSAL TACHYCARDIA
    TAQUICARDIA SINUSAL INDUCIDA POR LA QUEMADURA
    E.1.1.1Medical condition in easily understood language
    BURNT-INDUCED SINUSAL TACHYCARDIA
    TAQUICARDIA SINUSAL INDUCIDA POR LA QUEMADURA
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    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
    Assess the effect of treatment with propranolol in the adult burnt patient with sinusal tachycardia by measuring its effect on the resting energy expenditure.
    Comprobar el efecto del tratamiento con propranolol en el paciente quemado adulto intubado con taquicardia sinusal mediante la medición de la magnitud de la disminución del gasto energético
    E.2.2Secondary objectives of the trial
    o Assess the effect of the treatment of sinusal tachycardia with propranolol in the morbidity and mortality of the burned patient (sepsis, infections, necessity of inotropic agents, burn wound colonization).
    o Assess the effect of the treatment of sinusal tachycardia with propranolol on wound healing (graft intake and donor sites´ epithelialization).
    • Valorar el efecto de la disminución de la administración de propranolol para el tratamiento de la taquicardia sinusal del paciente quemado intubado sobre su morbi-mortalidad (sepsis, infecciones, necesidad de soporte inotrópico, colonización de quemaduras).
    • Valorar el efecto de la administración de propranolol para el tratamiento de la taquicardia sinusal del paciente quemado intubado sobre su cicatrización (prendimiento de injertos y epitelización de zonas donantes de injertos).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Burnt patients with mechanical ventilation, between 14 and 75 years of age, with sinusal tachycardia (>100 bpm), admitted to our Burns Unit during an estimated period of 2 years.
    Pacientes quemados mayores de 14 años y menores de 75 años con taquicardia sinusal (>100 latidos por minuto) y necesidad de ventilación mecánica invasiva, ingresados en nuestra Unidad durante un periodo estimado de 2 años.
    E.4Principal exclusion criteria
    Patients in whom beta-blockers are contraindicated.
    Patients with beta-blocker treatment before admission.
    Unsigned Informed Consent
    Se excluyen del estudio aquellos pacientes en los que esté contraindicada la administración de beta-bloqueantes y aquellos que ya estaban beta-bloqueados antes del ingreso.
    Consentimiento Informado no firmado
    E.5 End points
    E.5.1Primary end point(s)
    Resting energy expenditure and respiratory quotient (VCO2/VO2)
    Gasto energético en reposo y cociente respiratorio (VCO2/VO2
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.At the time of admission
    2. Daily until 2 weeks post injury
    1. Al ingreso
    2. Diarios hasta completar 2 semanas post lesion.
    E.5.2Secondary end point(s)
    -HR and BP
    -Caloric intake
    -Need of sedoanalgesia
    -Inotropic agents
    -Days of inotropic agents administration
    -Number of surgical procedures needed
    -Healing time for donor sites
    -Graft intake 5 days after surgery
    -Burn wound colonization
    -Burn wound infection or donor site infection
    -Other infections
    -Sepsis
    -Mortality
    -Frecuencia cardíaca y TA diarias:
    -Aportes calóricos totales
    -Sedoanalgesia
    -Necesidad de inotrópicos
    -Días necesarios de inotrópicos
    -Intervenciones quirúrgicas
    -Tiempo de cicatrización de las heridas (zonas donantes)
    -Porcentaje de prendimiento de injertos a los 5 días de la cirugía
    -Colonización de quemaduras
    -Infección de quemaduras o zonas donantes
    -Otras infecciones
    -Sepsis
    -Mortalidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.At the time of admission
    2. Daily until 2 weeks post injury
    1. Al ingreso
    2. Diarios hasta completar 2 semanas post lesion.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no tratado
    untreated
    E.8.2.4Number of treatment arms in the trial2
    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 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
    Ultima visita del ultimo paciente
    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 months6
    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: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    INTUBATED PATIENTS
    PACIENTES INTUBADOS
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents over 14 / Elderly under 75
    Adolescentes mayores de 14 / Ancianos menores de 75
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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