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    Summary
    EudraCT Number:2013-003664-32
    Sponsor's Protocol Code Number:201301
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-11
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003664-32
    A.3Full title of the trial
    ‘Effect of omega-3 fatty acids on the perioperative immune response and erythrocyte function’
    'Het effect van omega-3 vetzuren op de peri-operatieve immuunreactie en erythrocyt functie'
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of fish oil on the immune system and red blood cell function of patients around surgery.
    Het effect van visolie op het afweersysteem en de functie van de rode bloedcel bij patiënten rondom een operatie.
    A.3.2Name or abbreviated title of the trial where available
    EMPIRE-study
    EMPIRE-studie
    A.4.1Sponsor's protocol code number201301
    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 SponsorMedical Center Alkmaar
    B.1.3.4CountryNetherlands
    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 supportFresenius Kabi Nederland B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Center Alkmaar
    B.5.2Functional name of contact pointTrial Center Holland Health
    B.5.3 Address:
    B.5.3.1Street AddressKennemerstraatweg 10
    B.5.3.2Town/ cityAlkmaar
    B.5.3.3Post code1815LA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031725484444
    B.5.5Fax number0031725482422
    B.5.6E-mailj.van.wissen@mca.nl
    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 Omegaven-Fresenius
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Patients undergoing colon surgery for malignancy.
    Patienten die een dikke darm operatie ondergaan wegens coloncarcinoom.
    E.1.1.1Medical condition in easily understood language
    Patients that suffer from large bowel cancer and will undergo surgery to remove a part of the large bowel.
    Patiënten met dikke darmkanker die een operatie krijgen om een deel van de darm te verwijderen.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009951
    E.1.2Term Colon cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009950
    E.1.2Term Colon cancer Duke's D
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009946
    E.1.2Term Colon cancer Duke's A
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009947
    E.1.2Term Colon cancer Duke's B1
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009948
    E.1.2Term Colon cancer Duke's B2
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009949
    E.1.2Term Colon cancer Duke's C
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of intravenous Omegaven® on the production of cytokine interleukin-6 in ex vivo LPS stimulated whole blood cells in patients undergoing laparoscopic surgery for colon cancer, compared to an intravenous saline treated control group.
    Het effect van intravenous Omegaven op de productie van Interleukine-6 in ex vivo LPS gestimuleerd volbloed in patienten die een hemicolectomie ondergaan wegens coloncarcinoom, vergeleken met intraveneus NaCl 0.9%.
    E.2.2Secondary objectives of the trial
    •The effect of intravenous Omegaven® on the production of cytokines TNF-α and Interleukin-10 in ex vivo LPS stimulated whole blood cells.
    •The effect of intravenous Omegaven® on erythrocyte function.
    •The effect of intravenous Omegaven® on the in vivo systemic inflammatory response, including white blood cell count, C-reactive protein and cytokine levels in serum.
    •The effect of intravenous Omegaven® on mRNA expression of NFKappaB and IKappaB in leucocytes.
    •The effect of intravenous Omegaven® on perioperative plasma glutamine levels.
    •The effect of intravenous Omegaven® on postoperative outcome.
    •Het effect van omegaven op de productie van cytokines TNF-α en Interleukine-10 in ex vivo LPS gestimuleerd volbloed .
    •Het effect van omegaven op de functie van de rode bloedcel.
    •Het effect van omegaven op de systemische immuunrespons, o.a. leukocytenaantal, CRP and cytokines in serum.
    •Het effect van omegaven op mRNA expressie van NFKappaB and IKappaB in leukocytes.
    •Het effect van omegaven op perioperatieve glutamine waarden.
    •Het effect van omegaven op de postoperatieve uitkomst.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
    •Age between 60 and 80 years
    •BMI between 20 kg/m2 and below 30 kg/m2
    •Written informed consent
    •Patienten (man of vrouw) die electieve laparoscopische chirurgie ondergaan wegens coloncarcinoom
    •Leeftijd tussen 60 en 80
    •BMI tussen 20 kg/m2 en onder 30 kg/m2
    •Schriftelijk toestemmingsverklaring
    E.4Principal exclusion criteria
    •Participation in or having participated in another clinical trial within the previous 3 months
    •Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve
    •Bleeding disorders, determined by medical history and laboratory tests of clotting indices
    •Metastatic disease
    •Recent cardiac or cerebral infarction within the last 6 months
    •Current history of inflammatory or infectious disease
    •The use of anti-inflammatory drugs
    •The use of thyroid medication
    •The use of fish oil products or fish consumption more than 2 times a week
    •Contra-indications for the use of Omegaven-Fresenius
    •Huidige deelname in een ander onderzoek of deelname in de afgelopen 3 maanden.
    •Indicatie voor voortdurend gebruik van antistollings medicatie, zonder mogelijkheid om deze perioperatief te stoppen, bijvoorbeeld patienten met een mechanische hartklep.
    •Stollingstoornissen, vastgesteld door anamnese en laboratorium testen van stollingsparameters.
    •Metastasen op afstand.
    •Recent hart- of herseninfarct in de afgelopen 6 maanden.
    •Voorgeschiedenis van inflammatoire- of infectieziekten.
    •Gebruik van anti-inflammatoire medicijnen.
    •Gebruik van schildklier medicatie.
    •Gebruik van visolie producten of visconsumptie vaker dan 2 keer per week.
    •Contra-indicaties voor het gebruik van Omegaven-Fresenius
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter is the ex-vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood cells
    De primaire uitkomstmaat is de ex-vivo productie van pro-inflammatoire cytokine IL-6 in LPS gestimuleerd volbloed
    E.5.1.1Timepoint(s) of evaluation of this end point
    The second postoperative day.
    De tweede postoperatieve dag.
    E.5.2Secondary end point(s)
    •Levels of TNF-α and IL-10 in whole blood cells after stimulation with LPS
    •Erythrocyte function, measured as
    o deformability
    o aggregability
    •Systemic inflammatory cytokine response measured as plasma levels of:
    oC-reactive protein
    oWBC
    oCytokines TNF-α, IL-6 and IL-10
    The effect of surgery on cognitive function
    The effect of omega-3 fatty acids on cognitive function
    •Waarden van TNF-α and IL-10 in volbloed na LPS stimulatie
    •Functie van de rode bloedcel, gemeten als
    o deformabiliteit
    o aggregabiliteit
    •Systemische immuunreactie, gemeten als serumwaarden van:
    o C-reactive protein
    o WBC
    o Cytokines TNF-α, IL-6 and IL-10
    Het effect van de operatie op cognitieve functie
    Het effect van omega-3 vetzuren op cognitieve functie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples for ex vivo whole blood stimulation, erythrocyte function, plasma cytokines and other plasma measures are drawn on 6 time points (T=1 is 8 am the day before surgery (day=-1), T=2 is at the start of surgery (day =0), T=3 is 1 hr after the start of surgery (day =0), T=4, 5, and 6 are at 8 am on the first, second and fourth postoperative day).
    Bloedmonsters voor ex vivo volbloedstimulatie, functie van de rode bloed cel, plasma cytokines en andere waarden worden afgenomen op 6 tijdsmomenten (T=1 is 8 uur 's ochtends de dag voor de operatie, T=2 is bij het begin van de operatie, T=3 is 1 uur na start van de operatie, T=4, 5 en 6 zijn om 8 uur 's ochtends op de 1e, 2e en 4e dag na operatie.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NaCl 0,9% 2ml/kg lichaamsgewicht
    NaCl 0,9% 2ml/kg bodyweight
    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
    The end of the trial is defined as four weeks after surgery.
    Het einde van het klinisch onderzoek is vier weken na de operatie.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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) No
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state44
    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
    Geen
    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 Decision2013-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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