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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-000051-24
    Sponsor's Protocol Code Number:RemiPedEntropy_v1.0
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-23
    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 ConcernedFinland - Fimea
    A.2EudraCT number2015-000051-24
    A.3Full title of the trial
    The pharmacokinetics and –genomics of remifentanil, and its effects on the depth-of-anaesthesia monitors and the protein synthesis in children.
    Remifentaniilin farmakokinetiikka ja –genomiikka sekä remifentaniilin vaikutukset anestesiasyvyysmittareihin ja elimistön proteiinisynteesiin lapsilla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Remifentanil in children
    Remifentaniili lapsilla
    A.4.1Sponsor's protocol code numberRemiPedEntropy_v1.0
    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 SponsorKlaus Olkkola/University of Helsinki
    B.1.3.4CountryFinland
    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 organisationKlaus Olkkola/University of Helsinki
    B.5.2Functional name of contact pointKlaus Olkkola
    B.5.3 Address:
    B.5.3.1Street AddressHaartmanninkatu 4 (PL 340)
    B.5.3.2Town/ cityHUS Helsinki
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    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 Remifentanil Orion 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 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 INNREMIFENTANIL
    D.3.9.1CAS number 132875-61-7
    D.3.9.4EV Substance CodeSUB10272MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 to 25
    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 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 Propofol Lipuro 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 namepropofol
    D.3.4Pharmaceutical form 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 INNpropofol
    D.3.9.3Other descriptive namePROPOFOL
    D.3.9.4EV Substance CodeSUB10116MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    otherwise healthy patients undergoing an operation necessitating general anaesthesia
    E.1.1.1Medical condition in easily understood language
    healthy pediatric patients who come to an operation which is done under general anaesthesia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    Our aim is to study the effects of remifentanil on the entropy measurement in paediatric patients during general anaesthesia.
    Tutkimuksen tavoitteena on selvittää remifentaniilin vaikutukset entropiaan (RE, SE, RE-SE-ero) lapsipotilailla yleisanestesian yhteydessä
    E.2.2Secondary objectives of the trial
    2. To evaluate the effects of surgery pain and remifentanil analgesia to surgigal pleth index (SPI) and entropy measurement and their microdeviation.
    3. To evaluate the usefulnes of entropy-measurement in assessing awakening from general anaesthesia.
    4. To evaluate the usefulness of target-controlled infusion -dosing during awakening period of anaesthesia.
    5. To create pharmacokinetic-pharmacodynamic model for remifentanil to be used in target controlled analgesia in pediatric patients.
    6. To characterise propofol-remifentanil drug interactions
    7. To characterise genomic factors affecting remifentanil analgesia.
    8. To characterise remifentanil induced changes in protein expression.
    2. Selvittää leikkauskivun ja remifentaniilin vaikutukset surgical pleth index:iin (SPI) ja sekä SPI:n ja entropiamittauksen mikrodeviaatioon (ΔSPI, ΔRE, ΔSE).
    3. Tutkia entropian toimivuus anestesiasta heräämisessä.
    4. Tutkia propofolin TCI-annostelun toimivuus erityisesti heräämisvaiheessa.
    5. Mallintaa remifentaniilin farmakokinetiikka ja –dynamiikka remifentaniilin TCI-annostelun mahdollistamiseksi lapsipotilailla.
    6. Tutkia ja mallintaa remifentaniilin ja propofolin yhteisvaikutuksia.
    7. Selvittää remifentaniilin kivunlievitykseen vaikuttavat geneettiset tekijät.
    8. Selvittää remifentaniilin aiheuttamat muutokset elimistön proteiinien synteesissä ja ilmentymisessä.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient is 3-15 years old (body weight (15-61 kg). Patients ASA class is 1-2. Patient comes to an elective surgery which necessitates general anesthesia. Operation time is appr. 1.5-6 hours
    Potilas on 3-15 vuotias (paino 15-61 kg), Potilaan ASA-luokka on 1-2, Potilaalle on suunniteltu elektiivinen yleisanestesian vaativa arviolta 1.5-6 tuntia kestävä toimenpide.
    E.4Principal exclusion criteria
    Patient has a disease or trauma affecting the state of consciousnes or encephaloelectrogram measurement. Patient comes to a head or neck surgery. Anaesthesia cannot be induced via intravenous route. The researchers cannot place the second iv-cannula. Muscle relaxant is needed. Patient or his/her guardians refuse to take part in the study
    Potilaalla on tiedossa oleva tajunnan tasoon tai aivosähkökäyrään vaikuttava sairaus tai vamma. Suunniteltu toimenpide kohdistuu päähän tai kaulaan. Anestesian induktio ei onnistu laskimoteitse. Potilaalle ei saada toista laskimokanyylia. Joudutaan käyttämään lihasrelaksanttia. Potilas tai hänen vanhempansa kieltävät potilaan osallistumisen tutkimukseen.
    E.5 End points
    E.5.1Primary end point(s)
    All the planned SPI and entropy measurements have been done.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after the start of remifentanil dosing.
    E.5.2Secondary end point(s)
    All the planned blood samples have been drawn.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours after the start of remifentanil dosing
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 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
    24 hour after the start of remifentanil dosing, when the surgery is completed as planned and all the measurements and blood samples have been taken or drawn.
    24 tuntia remifentaniilin annostelun alkamisesta, kun leikkaus on saatu tehdyksi suunnitellusti, ja kaikki suunnitellut näytteet on otettu ja mittaukset on tehty.
    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 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state60
    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 (normal care in the patient ward).
    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 Decision2015-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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