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    Summary
    EudraCT Number:2015-002667-42
    Sponsor's Protocol Code Number:ABR53999
    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:2015-09-02
    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 number2015-002667-42
    A.3Full title of the trial
    Sedation with propofol TCI during ERCP: Is the combination with esketamine more effective and safer than with alfentanil (SPEKA): A randomized controlled multicentre trial
    Sedatie met propofol TCI tijdens ERCP: Is de combinatie met esketamine effectiever en veiliger dan met alfentanil (SPEKA): Een gerandomiseerd gecontroleerd multicenter onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two forms of sedation during endoscopic inspection of the liver and bile ducts
    Vergelijking van twee vormen van sedatie tijdens endoscopisch onderzoek van de lever en galwegen
    A.3.2Name or abbreviated title of the trial where available
    SPEKA
    A.4.1Sponsor's protocol code numberABR53999
    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 SponsorAMC
    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 supportAMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMC
    B.5.2Functional name of contact pointClinical Trial information
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100DD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205669111
    B.5.5Fax number+31206979441
    B.5.6E-mailb.preckel@amc.uva.nl
    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 Rapifen
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag BV.
    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.3.1Product nameAlfentanil hydrochlorid
    D.3.2Product code no
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeopioid analgesic
    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 Ketanest S
    D.2.1.1.2Name of the Marketing Authorisation holderEurocept BV
    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.3.1Product nameesketamine
    D.3.2Product code n.a.
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeKetanest S is a non-competitive NMDA-receptor antagonist.
    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 ERCPs under propofol sedation combined with ketamine or alfentanil given by trained anesthesia nurse.
    Patiënten die een ERCPs onder propofol sedatie in combinatie met ketamine of alfentanil moeten ondergaan gegeven door getrainde anesthesie verpleegkundige.
    E.1.1.1Medical condition in easily understood language
    Patients with an disease of the liver or bile ducts which is treated by means of endoscopic instruments. During this therapy patients will be sedated by trained anesthesia nurses.
    Patiënten met een ziekte van lever- of galwegen die door middel van endoscopie wordt behandeld. Tijdens deze therapie worden de patiënten door getrainde anesthesie verpleegkundigen gesedeerd.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Primary objectives reflect the effectiveness of coadministration of propofol and esketamine.
    Will this combination of propofol and ketamine allow for a reduction in the total dosage of propofol and so result in faster recovery time with less side effects? Is the level of sedation and analgesia sufficient to perform the procedure?
    Are patients more satisfied?
    Primaire doelstellingen doelt op de effectiviteit van gelijktijdige toediening van propofol en esketamine.
    Kan deze combinatie van propofol en ketamine voor een vermindering van de totale dosering van propofol zorgen, en zo tot een snellere hersteltijd met minder neveneffecten leiden? Is het niveau van sedatie en analgesie voldoende om de procedure uit te voeren?
    Is de tevredenheid van de patienten hoger?
    E.2.2Secondary objectives of the trial
    Which form of sedation is safer for the patient in regard to respiratory
    and cardiovascular problems? Surrogate parameters of pulmonary and
    cardiovascular problems are oxygen saturation (SO2) measured by pulse
    oximetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG)
    and blood pressure (non-invasive blood pressure measurement (NIBP).
    Welke vorm van sedatie is veiliger voor de patiënt met betrekking tot
    ademhaling- en cardiovasculaire problemen? Surrogaat parameters van
    pulmonale en cardiovasculaire problemen zijn zuurstofverzadiging (SO2)
    gemeten door pulsoximetrie, uitgeademd CO2 (capnografie), hartslag,
    hartfrequentie (ECG) en bloeddruk (niet-invasieve bloeddrukmeting
    (NIBP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients must comply with the following criteria in order to be eligible to participate in this clinical study:
    Age range ≥ 18 years
    ASA classification I – III
    Planned ERCP procedure
    Written informed consent
    De patiënten moeten aan de volgende criteria voldoen om in aanmerking voor deelname aan deze klinische studie te komen:
    Leeftijd ≥ 18 jaar
    ASA classificatie I - III
    Geplande ERCP procedure
    informed consent
    E.4Principal exclusion criteria
    Patient will be excluded if the following criteria are applicable:
    Age range < 18 years
    ASA classification IV and V
    Allergic reaction to planned medication in the patients’ medical history
    Unregulated hypertension
    History of malignant hypertension
    Significant ischaemic heart disease
    Mentally disordered
    History of psychological problems or psychiatric disease
    Use of drugs that affect the central nervous system
    Substance abuse
    Chronic pain
    Pregnancy
    Seizure disorders
    Increased intracranial pressure
    Patiënt worden uitgesloten als de volgende criteria van toepassingz ijn :
    Leeftijd <18 jaar
    ASA classificatie IV en V
    Allergische reactie op de geplande medicatie in de medische voorgeschiedenis van de patiënten '
    Niet gereguleerde hypertensie
    Voorgeschiedenis van maligne hypertensie
    Cardiale ischemie
    Voorgeschiedenis van psychische problemen of psychiatrische ziekte
    Het gebruik van geneesmiddelen die het centrale zenuwstelsel kunnenbeïnvloeden
    geneesmiddelenmisbruik
    chronische pijn
    zwangerschap
    Verhoogde intracraniële druk
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameters, reflecting effectiveness of esketamine are the total dosage of propofol, recovery time, and satisfaction with the procedure of patients and endoscopists.
    Hoofdonderzoeks parameters, als gevolg van de effectiviteit van esketamine is de totale dosering van propofol, de hersteltijd, en tevredenheid van patiënt en endoscopist met de procedure .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Satisfaction levels are measured by means of questionnaires pre- and
    post procedure (30min post) and in case of the patient on the following
    day. Dosage of propofol and recovery time is documented.
    Tevredenheid wordt gemeten door middel van vragenlijsten voor en na
    de procedure (30min post) en in het geval van de patiënt op de volgende
    dag. De dosis van propofol en de herstel tijd wordt gedocumenteerd.
    E.5.2Secondary end point(s)
    Secondary study parameters include in patients measurement of oxygen
    saturation (SO2) measured by pulseoxymetry, exhaled CO2
    (capnography), heart rate, arrhythmias (ECG) and blood pressure (noninvasive
    blood pressure measurement, NIBP). These parameters are
    surrogate parameters of pulmonary and cardiovascular problems,
    experienced by the patient during sedation.
    Verdere parameters zijn saturatie metingen middels pulsoxymeter,
    endexpiratoire CO2, hart frequentie, aritmie en bloed druk. Deze
    parameters zijn surrogaatparameters voor pulmonale en kardinale
    aandoeningen bij de patiënt. Ze zijn daarmee afspiegelingen van het
    heersende veiligheidsniveau
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measurements take place during procedure and recovery period.
    Metingen vinden plaats tijdens de procedure en de herstelperiode
    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 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 Yes
    E.6.13.1Other scope of the trial description
    satisfaction
    tevredenheid
    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 Yes
    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) 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 concerned3
    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 Yes
    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 trail ends one day after including the 166. patient and performing
    the ERCP with the interview with the last patient on
    phone.
    De trial eindigt met het afsluitende telefoongesprek met de 166. patient
    op de dag nadat de ERCP bij dezelfde patiënt heeft
    plaatsgevonden.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 66
    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 state166
    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 Decision2015-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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