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    Summary
    EudraCT Number:2016-000884-17
    Sponsor's Protocol Code Number:MOME
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-09
    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 number2016-000884-17
    A.3Full title of the trial
    A multicenter, open-label, randomized of MOrphine and MEperidine in patients admitted for acute heart failure in emergency departments: the MOME study
    Ensayo clínico, multicéntrico, randomizado, abierto de la administración de MOrfina frente a MEperidina en pacientes con
    insuficiencia cardíaca aguda: "Estudio MOME".
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Morphine and meperidine in acute heart failure.
    Morfina y meperidina en la insuficiencia cardiaca aguda.
    A.3.2Name or abbreviated title of the trial where available
    Estudio MOME
    A.4.1Sponsor's protocol code numberMOME
    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 SponsorDr Alberto Domínguez-Rodríguez
    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 supportSociedad Española de Cardiología
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de Canarias
    B.5.2Functional name of contact pointDra Ana Aldea
    B.5.3 Address:
    B.5.3.1Street AddressOfra s/n. La Cuesta.
    B.5.3.2Town/ cityLa Laguna
    B.5.3.3Post code38320
    B.5.3.4CountrySpain
    B.5.4Telephone number34922678117
    B.5.5Fax number34922677284
    B.5.6E-mailaaldperh@gobiernodecanarias.org
    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 namemeperidina
    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 INNPETHIDINE
    D.3.9.1CAS number 57-42-1
    D.3.9.4EV Substance CodeSUB09738MIG
    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.2.5The 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 namemorphine hydroclorure
    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 INNMORPHINE HYDROCHLORIDE
    D.3.9.1CAS number 52-26-6
    D.3.9.3Other descriptive nameMORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14596MIG
    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
    Acute heart failure is the rapid development or change of signs and symptoms of heart failure that requires medical attention and usually leads to patient hospitalization
    La insuficiencia cardiaca aguda consiste en la instauración o cambio rápido de signos y síntomas de insuficiencia cardiaca que requieren atención médica y, generalmente, conducen a la hospitalización del paciente.
    E.1.1.1Medical condition in easily understood language
    Acute heart failure defined as a fast onset of clinical changes in new patients or in patients with descompensation that required treatment urgently.
    Pacientes con insuficiencia cardíaca aguda de rápido inicio o en pacientes con insuficiencia cardíaca descompensada que requieran tratamiento urgente..
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our objective is to assess in-hospital mortality
    associated with intravenous opioids use(morphine vs meperidine) in patients with acute heart failure
    Evaluar mortalidad intrahospitalaria asociada al uso de opioides intravenosos ( morfina versus meperidina) en pacientes con insuficiencia cardíaca aguda.
    E.2.2Secondary objectives of the trial
    a) Need to patient to require mechanical ventilation.
    b) Stay in hospital
    c) Time and admission rate in the intensive care unit
    d) Need to patient to require cardiopulmonary resuscitation.
    a) Necesidad de ventilación mecánica invasiva.
    b) Estancia hospitalaria
    c) Estancia en la Unidad de Cuidados Intensivos
    d) Necesidad de reanimación cardiopulmonar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients admitted for acute heart failure in emergency departments and the following
    characteristics:

    - Adults more than 18 years of age.
    - Patients with anxiety and distress associated with dyspnoea.
    - Being willing and able to provide informed consent after written and oral information.
    Se incluirán a los enfermos que acudan al servicio de urgencias de los hospitales participantes con insuficiencia cardíaca aguda y que cumplan las siguientes condiciones:
    Edad 18-80 años
    Síntomas de ansiedad y/o disnea grave
    Que consientan participar en el estudio.
    E.4Principal exclusion criteria
    - Severe renal disease treated with dialysis.
    - Patients unlikely to cooperate in the study or with inability or unwillingness to give
    informed consent.
    - Expectation of death from other illness during the course of the trial.
    Los pacientes con insuficiencia cardíaca aguda que cumplan alguno de los siguientes requisitos no serán incluidos en el estudio:
    Pacientes en diálisis renal.
    Enfermedad concomitante severa con pronóstico disminuido a corto plazo.
    Incapacidad para dar consentimiento informado.
    Participación en otro estudio.
    E.5 End points
    E.5.1Primary end point(s)
    In-hospital mortality
    Mortalidad durante el ingreso hospitalario.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the hospitalization.
    Durante el ingreso hospitalario.
    E.5.2Secondary end point(s)
    a) Need to patient to require mechanical ventilation.
    b) Stay in hospital
    c) Time and admission rate in the intensive care unit
    d) Need to patient to require cardiopulmonary resuscitation.
    Necesidad de ventilación mecánica invasiva.
    Duración de la estancia hospitalaria
    Estancia en la Unidad de Cuidados Intensivos
    Necesidad de reanimación cardiopulmonar.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the hospitalization.
    Durante el ingreso hospitalario.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) 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 concerned9
    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
    El último día de seguimiento del último paciente reclutado
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state136
    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)
    The patient is followed along his hospitalization. After that, he/she will be followed by the specialist or by primary care.
    El seguimiento del paciente se realiza a lo largo de todo el ingreso hospitalario. La finalización en el ensayo clínico coincide con el alta hospitalaria del paciente. Por práctica clínica habitual será seguido en consultas por especialista or medico atención primaria.
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-03-03
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