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    Summary
    EudraCT Number:2016-004978-17
    Sponsor's Protocol Code Number:FAR-NP-2017-01
    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:2017-05-31
    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 number2016-004978-17
    A.3Full title of the trial
    CLINICAL, RANDOMIZED, DOUBLE LIND CLINICAL TRIAL TO STUDY THE EFFECT OF PARENTERAL SUPPLEMENTATION WITH FISH OIL EMULSION IN THE NUTRITIONAL SUPPORT IN ESOPHAGECTOMIZED PATIENTS
    ENSAYO CLÍNICO PILOTO, RANDOMIZADO, DOBLE CIEGO, PARA ESTUDIAR EL EFECTO DE LA SUPLEMENTACIÓN PARENTERAL CON EMULSIÓN DE ACEITE DE PESCADO EN EL SOPORTE NUTRICIONAL EN PACIENTES ESOFAGECTOMIZADOS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to purchase the effect of supplementation with intravenous fish oil on the evolution of esophagectomized patients
    Ensayo clínico para comprabar el efecto de suplementar con aceite de pescado intravenoso en la evolución de los pacientes esofagectomizados
    A.3.2Name or abbreviated title of the trial where available
    Intravenous fish oil in esophagectomized patients
    Aceite de pescado intravenoso en pacientes esofagectomizados
    A.4.1Sponsor's protocol code numberFAR-NP-2017-01
    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 SponsorHospital Universitari Bellvitge
    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 supportHospital Unversitari Bellvitge
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Bellvitge
    B.5.2Functional name of contact pointPharmacy Department
    B.5.3 Address:
    B.5.3.1Street AddressC/Feixa Llarga s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number349326075042038
    B.5.5Fax number34932607507
    B.5.6E-mailmbadia@bellvitgehospital.cat
    D. IMP Identification
    D.IMP: 1
    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 Omegaven Fish oil intravenous emulsion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius-Kabi
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameOmegaven
    D.3.4Pharmaceutical form Emulsion for infusion
    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 INNEicosapentanoic acid
    D.3.9.1CAS number 25378-27-2
    D.3.9.2Current sponsor codePL 3457/0011
    D.3.9.3Other descriptive nameEICOSAPENTAENOIC ACID
    D.3.9.4EV Substance CodeSUB13664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.25 to 3.09
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDocosahexaenoic acid
    D.3.9.1CAS number 6217-54-5
    D.3.9.2Current sponsor codePL 3457/0011
    D.3.9.3Other descriptive nameDOCOSAHEXAENOIC ACID
    D.3.9.4EV Substance CodeSUB121918
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.44 to 3.09
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Esophagectomy due to esophageal neoplasia
    Esofagectomia por neoplasia de esófago
    E.1.1.1Medical condition in easily understood language
    Esophagectomy due to esophageal neoplasia
    Esofagectomia por neoplasia de esófago
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067473
    E.1.2Term Immunomodulatory therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10044107
    E.1.2Term Total parenteral nutrition
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10015460
    E.1.2Term Esophagectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10024587
    E.1.2Term Lipids
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to determine whether, in esophagectomized patients, the administration of 5 days of fish oil intravenous lipid emulsions normalized the intraleukin-6 (IL-6). To determine whether 5-day administration of endovenous lipid emulsions derived from fish oil in esophagectomized patients at a dose of 0.8 g / kg / day is more effective than a dose at 0.4 g / kg / day in reducing the Inflammation expressed in terms of serum concentration of Interleukin-6.
    El objetivo principal es determinar si la administración durante 5 días de emulsiones lipídicas endovenosas de aceite de pescado en pacientes esofagectomizados es efectiva en la normalización de la Interleukina-6 (IL-6). Determinar si la administración durante 5 días de emulsiones lipídicas endovenosas derivadas del aceite de pescado en pacientes esofagectomizados, a una dosis de 0,8 g/Kg/día es más efectiva que una dosis a 0,4 g/Kg/día en reducir la inflamación expresada en términos de concentración sérica de Interleukina-6.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the study of other inflammatory markers (C-reactive protein, alpha tumor necrosis factor, IL-10, IL-8 and soluble CD25), morbidity, safety, nutrition, and mortality parameters.
    Los objetivos secundarios incluyen el estudio de otros marcadores de inflamación (Proteína C reactiva, Factor de Necrosis Tumoral alfa, IL-10, IL-8 y CD25 soluble), parámetros de morbilidad, seguridad, nutrición y mortalidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients diagnosed with esophageal cancer who underwent an esophagectomy using Ivor-Lewis or MacEwan techniques, who meet ALL criteria for inclusion, will be included in the study:
    1. Minimum age of 18, of both sexes and of any race / ethnicity.
    2. Willing to give their IC in writing for the trial and be able to do so. If a subject can not independently give their IC in writing, they can do so by their legal representative in their place.
    3. With a pathway to the digestive tract
    Serán incluidos en el estudio aquellos pacientes diagnosticados de cáncer de esofágo, a los que se les practique una esofagectomía por las técnicas de Ivor-Lewis o MacEwan, que cumplan TODOS los criterios de inclusión:
    1. Edad mínima de 18 años, de ambos sexos y de cualquier raza/etnia.
    2. Dispuestos a otorgar su CI por escrito para el ensayo y ser capaces de hacerlo. Si un sujeto no puede otorgar su CI por escrito de forma independiente, podrá hacerlo su representante legal en su lugar.
    3.Con una vía de acceso al tubo digestivo
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will not be included in the study:
    1. Have a history of type I hypersensitivity or idiosyncratic reactions to any component of intravenous lipid emulsions.
    2. Pregnant or lactating women
    3. Have plasma triglycerides> 3 mmol / L
    4. Treated with chronic steroids or immunosuppressants in the previous month.
    5. Have AIDS or be transplanted.
    6. Hepatic dysfunction: with Child-Pugh grade B (significant functional compromise) and grade C (decompensated disease).
    No serán incluidos en el estudio aquellos pacientes que cumplan cualquiera de los siguientes criterios de exclusión:
    1. Tener antecedentes de hipersensibilidad de tipo I ni de reacciones idiosincrásicas a ningún componente de las emulsiones lipídicas intravenosas.
    2. Mujeres embarazadas o en período de lactancia
    3. Tener triglicéridos plasmáticos >3 mmol/L
    4. Tratados con corticoides de forma crónica o inmunosupresores en el mes previo.
    5. Padecer SIDA ó ser trasplantados.
    6. Disfunción hepática: con Child-Pugh grado B (compromiso funcional significativo) y grado C (enfermedad descompensada).
    E.5 End points
    E.5.1Primary end point(s)
    Interleukin-6 will be determined as the main variable.
    Se determinará como variable principal la Interleukina-6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be collected on days 0, 1, 3, 5 and 21
    Se recogerán muestras sanguíneas los días 0, 1, 3, 5 y 21
    E.5.2Secondary end point(s)
    We will determine others inflammatory parameters (C-reactive Protein, Tumor Necrosis Factor alpha, IL-10, IL-8 and soluble CD25), nutritional, hepatic and Safety (INR, platelets).
    Se determinarán otrosparámetros inflamatorios (Proteína C reactiva, Factor de Necrosis Tumoral alfa, IL-10, IL-8 y CD25 soluble), nutricionales, hepáticos y de seguridad (INR, plaquetas).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be collected on days 0, 1, 3, 5 and 21
    Mortality will be determined one year after inclusion in the study
    Se recogerán muestras sanguíneas los días 0, 1, 3, 5 y 21.
    La mortalidad se determinará transcurrido un año de la inclusión en el 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial3
    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
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    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 Decision2017-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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