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    Summary
    EudraCT Number:2007-005611-26
    Sponsor's Protocol Code Number:ELomega3
    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:2008-09-19
    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 number2007-005611-26
    A.3Full title of the trial
    Estudio comparativo del impacto de dos emulsiones lipídicas, una formulada con MCT, LCT, aceite de oliva y ácidos grasos omega 3 versus otra emulsión lipídica formulada con MCT y LCT, administradas por vía parenteral, en la evolución clínica de la pancreatitis aguda grave.
    (Comparative estudy about the impact of two oil emulsions, one of them formulated with MCT, LCT, olive oil and omega 3 fatty acids versus another one formulated with MCT and LCT, administered intravenously on severe acute pancreatitis clinical evolution).
    A.4.1Sponsor's protocol code numberELomega3
    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 SponsorFundació Institut de Recerca, Hospital Santa Creu i Sant Pau
    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 SMOFlipid 20% Emulsión para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI AB
    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 Emulsion for infusion
    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 INNACEITE PESCADO
    D.3.9.3Other descriptive nameFISH OIL
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIGLICERIDOS CADENA MEDIA
    D.3.9.3Other descriptive nameTRIGLICERIDOS CADENA MEDIA
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACEITE SOJA PURIFICADO
    D.3.9.1CAS number 8001-22-7
    D.3.9.3Other descriptive nameACEITE SOJA PURIFICADO
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACEITE OLIVA
    D.3.9.1CAS number 8001-25-0
    D.3.9.3Other descriptive nameOLIVE OIL
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 LIPOFUNDINA MCT/LCT 20% EMULSIÓN
    D.2.1.1.2Name of the Marketing Authorisation holderB. BRAUN MEDICAL, 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.3.4Pharmaceutical form Emulsion for infusion
    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 INNTRIGLICERIDOS CADENA MEDIA
    D.3.9.3Other descriptive nameTRIGLICERIDOS CADENA MEDIA
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACEITE SEMILLA SOJA
    D.3.9.1CAS number 8001-22-7
    D.3.9.3Other descriptive nameACEITE SEMILLA SOJA
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pancreatitis aguda grave.
    (Severe acute pancreatitis).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000971
    E.1.2Term Acute pancreatitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Valorar comparativamente los posibles efectos antiinflamatorios de las emulsiones lipídicas endovenosas ricas en ácidos grasos poliinsaturados omega 3 y aceite de oliva versus las emulsiones lipídicas endovenosas formuladas exclusivamente con MCT y LCT sobre la evolución de los pacientes afectos de pancreatitis aguda grave, durante el período en el que necesiten soporte nutricional artificial con nutrición parenteral total (NPT) de modo exclusivo.
    E.2.2Secondary objectives of the trial
    - Valoración clínica comparativa del curso de la enfermedad, entendida como un proceso inflamatorio, hacia su resolución.
    - Evaluación de la influencia comparativa sobre el número de complicaciones, locales y/o sistémicas, derivadas de la pancreatitis aguda.
    - Valoración comparativa de la influencia sobre la estancia hospitalaria.
    - Evaluación comparativa de la duración de la NPT y sobre el adelantamiento en el paso hacia la nutrición enteral y/o alimentación (oral y/o con suplementos nutricionales).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnóstico de pancreatitis aguda (Practice Guidelines in Acute Pancreatitis, American College of Grastroenterology, American Journal of Grastroenterology, 2006): requiere dos de las siguientes tres características:
    a) Dolor abdominal característico de la pancreatitis aguda.
    b) Concentraciones séricas de amilasa y/o lipasa ?3 veces el límite superior del rango normal.
    c) TAC abdominal con hallazgos característicos de pancreatitis aguda.
    - Criterios de severidad de pancreatitis aguda grave diagnosticada en ?72h desde el ingreso:
    a) Índice de severidad de Balthazar del TAC abdominal (con contraste) en grado ?D.
    b) APACHE II ?8.
    c) PCR ?150 mg/L.
    - Imposibilidad de iniciar alimentación (oral o con suplementos nutricionales) y/o nutrición enteral durante los 5 días posteriores al diagnóstico y previsión de mantener la indicación de dieta absoluta ?5 días ante la presencia de:
    a) Pancreatitis aguda necrotizante o necrohemorrágica
    b) Ausencia de peristaltismo o íleo paralítico o isquemia intestinal
    c) Náuseas y/o vómitos y/o distensión abdominal y/o aumento de los enzimas hepáticos antes o después de iniciar la alimentación y/o nutrición enteral
    c) Dolor abdominal
    d) Obstrucción duodenal y/o gástrica externa que imposibilite la colocación (endoscópica o radiológica) de una sonda nasoyeyunal para iniciar nutrición enteral o la administración de ésta mediante una sonda nasogástrica.
    - ?3 mmol/L de triglicéridos en sangre.
    - Hombres y mujeres con edad igual o superior a 18 años.
    - Aceptación del consentimiento informado por el paciente o por un familiar si el enfermo estuviera inconsciente como consecuencia del tratamiento aplicado (p. ej. sedación).
    E.4Principal exclusion criteria
    - Hipersensibilidad conocida a las proteínas de pescado, huevo o soja.
    - Etiología hiperlipidemiante.
    - >3 mmol/L de triglicéridos en sangre.
    - Insuficiencia hepática grave.
    - Insuficiencia renal grave sin posibilidad de hemofiltración o diálisis.
    - Alteraciones graves de la coagulación sanguínea.
    - Shock agudo.
    - Contraindicaciones generales de una terapia de perfusión.
    - Condiciones de inestabilidad clínica en pacientes que contraindiquen la nutrición parenteral.
    - Que tengan como comorbilidad otras patologías inflamatorias agudas o crónicas.
    - Estado de inmunosupresión severa debido a:
    a) Tratamiento citotóxico en los 15 días previos a la inclusión en el estudio.
    b) Una enfermedad que provoque niveles de leucocitos <5000/mm3.
    - Tratamiento con esteroides >0.25 mg/kg/día de prednisona o con dosis equivalentes de corticoesteroides.
    a) como tratamiento habitual preingreso
    b) durante el ingreso.
    E.5 End points
    E.5.1Primary end point(s)
    Determinación de la evolución de la inflamación mediante análisis sanguíneos de mediadores de la inflamación:
    - LTB4, TXB2, PG2
    - IL-6
    - TNF?
    - PCR
    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 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 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) 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 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) Yes
    E.8.2.2Placebo No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-09-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    Aquellos pacientes que por la propia evolución de la enfermedad requirieran ser ingresados en la unidad de cuidados intensivos y aquí fueran sedados para su intubación. Entonces, se solicitará el consentimiento informado al familiar más cercano.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 Decision2008-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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