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    The EU Clinical Trials Register currently displays   36775   clinical trials with a EudraCT protocol, of which   6073   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001587-35
    Sponsor's Protocol Code Number:Feline01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-09
    Trial results View 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 number2014-001587-35
    A.3Full title of the trial
    Dexmedetomidine in awake implantation of neuromodulative systems.
    Dexmedetomidine bij wakkere implantatie van een neuromodulatief systeem.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dexmedetomidine during the implantation of a neurostimulator in awake patients.
    Dexmedetomidine tijdens de implantatie van een zenuwstimulator bij een wakkere patient.
    A.3.2Name or abbreviated title of the trial where available
    DexMed
    DexMed
    A.4.1Sponsor's protocol code numberFeline01
    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 SponsorErasmus Medical Centre, Department of Anesthesiology
    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 supportErasmus Medical Centre, Department of Anesthesiology
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Centre, Department of Anesthesiology
    B.5.2Functional name of contact pointProf. Dr. F.J.P.M. Huygen
    B.5.3 Address:
    B.5.3.1Street Addresss-Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.6E-mailf.huygen@erasmusmc.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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    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 nameDexdor
    D.3.4Pharmaceutical form Concentrate and solvent for solution 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 INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.4EV Substance CodeSUB07037MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    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) 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
    Awake implantation of a neuromodulative system.
    De wakkere implantatie van een neuromodulatief systeem.
    E.1.1.1Medical condition in easily understood language
    The implantation of a neurostimulator in an awake patient.
    De plaatsing van een neurostimulator bij een wakkere patient.
    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
    Patient overall satisfaction.


    Algemene patient tevredenheid.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess clinical usefulness of Dexmedetomidine on
    - Hemodynamics (bloodpressure and heart rate),
    - Respiration (capnography and pulse oximetry),
    - Ramsey sedation scores,
    - Pain relief (NRS score),
    - Patient comfort score and operator comfort score,
    - The measurement of the number of adjustments of Dexmedetomidine titration
    Secundaire parameters zijn het beoordelen van het klinische nut van Dexmedetomidine door:
    - Hemodynamische meting (bloeddruk en hartslag)
    - Respiratoire meting (capnografie en pulse oxymetrie)
    - Ramsey sedatie score
    - Pijn score (NRS score)
    - Patient comfort score en operateur comfort score
    - Het meten van het aantal aanpassingen van Dexmedetomidine titratie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients need to be 18 years or older
    -Patients have an indication for implantation of a neuromodulative system.
    - Patienten moeten ouder dan 18 jaar zijn
    -Patienten met een indicatie voor implantatie van een neurmodulatief systeem
    E.4Principal exclusion criteria
    - Hypersensitivity of active part of one of any of the excipients
    - AV-block (II or III)
    - Acute cerebrovascular disease
    - Pregnancy
    - Acute epilepsy
    - Severe liver dysfunction
    - Use of a beta blocker.
    - Psychologically unstable
    - Communication problem.
    - Hypersensitiviteit van het actieve deel van Dexmedetomidine
    - AV-blok (II of III)
    - Acute cerebrovasculaire ziekte
    - Zwangerschap
    - Acute epilepsie
    - Ernstige leverdysfunctie
    - Gebruik van een beta blokker
    - Psychisch instabiel
    - Communicatie probleem
    E.5 End points
    E.5.1Primary end point(s)
    Does Dexmedetomidine improve the patient overall satisfaction in awake implantation of neurmodulative systems?
    Verbetert Dexmedetomidine de algemene patient tevredenheid tijdens implantatie van neurmodulatieve systemen bij wakkere patienten?
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes post-operative.
    1 day post-operative.
    30 minuten post-operatief
    1 dag post-operatief.
    E.5.2Secondary end point(s)
    Does Dexmedetomidine improve sedation and improve patient comfort and operator comfort? Does Dexmedetomidine decrease the clinical pain score and will Demedetomidine take care of a good control of the hemodynamic and respiratory values?

    Verbetert Dexmedetomidine de sedatie en verbetert Dexmedetomidine het comfort van de patient en het comfort van de operateur? Zal Dexmedetomidine de klinische pijnscore laten dalen en zal er goede controle mogelijk zijn van de hemodynamische en respiratoire waarden?
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 5 - 10 - 20 - 30 minutes during procedure after a step.
    Steps:
    - Baseline
    - Start Dexmedetomidine infusion
    - Start Analgetic infusion (Remifentanil)
    - Start of Procedure
    - Time of median incision
    - End of procedure
    - 1 day after procedure
    Elke 5 - 10 - 20 - 30 minuten tijdens de operatie na een stap.
    Stappen:
    - Baseline
    - Start Dexmedetomidine infuus
    - Start Analgetische infuus (Remifentanil)
    - Start operatie
    - Tijdstip van mediane incisie
    - Einde van operatie
    - 1 dag na operatie
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient overall satisfaction
    Algemene patient 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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
    LVLS
    LVLS
    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: 10
    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 state10
    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 Decision2014-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-16
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