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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2015-000882-29
    Sponsor's Protocol Code Number:001
    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:2016-02-17
    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 number2015-000882-29
    A.3Full title of the trial
    Spinal hyperbaric Prilocaine 2% 60 or 80 mg: a dosing study in day care patients.
    Prilocaine 2% hyperbaar voor spinaal anesthesie 60 of 80 mg: een doseringsstudie bij dagbehandelingspatienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dosing study with the anesthetic prilotekal for spinal anesthesia during day care surgery.
    Doseringsstudie met het middel prilotekal voor gebruik bij ruggenprikken tijdens dagchirurgie.
    A.3.2Name or abbreviated title of the trial where available
    Spinal hyperbaric Prilocaine 2% 60 or 80 mg: a dosing study in day care patients.
    Prilocaine 2% hyperbaar voor spinaal anesthesie 60 of 80 mg: een doseringsstudie bij dagbehandelings
    A.4.1Sponsor's protocol code number001
    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 SponsorReinier de Graaf Groep
    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 supportReinier de Graaf Groep
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReinier de Graaf Groep
    B.5.2Functional name of contact pointdepartment of anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressReinier de Graafweg 3-11
    B.5.3.2Town/ cityDelft
    B.5.3.3Post code2625AD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31152604928
    B.5.5Fax number+31152603224
    B.5.6E-mailverdouw@rdgg.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 Prilotekal
    D.2.1.1.2Name of the Marketing Authorisation holderNordic Group 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    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
    spinal anesthesia for open inguinal hernia repair or lower limb surgery
    spinaal anesthesie voor open liesbreukchirurgie of ingrepen aan de onderste ledematen
    E.1.1.1Medical condition in easily understood language
    spinal anesthesia for open inguinal hernia repair or lower limb surgery
    ruggenprik voor open liesbreukchirurgie of ingrepen aan de onderste ledematen
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10041538
    E.1.2Term Spinal anesthesia
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to obtain information on the level of anesthesia and moter block with prilotekal and the duration of anesthesia on that level with varying dosages
    informatie te krijgen over de hoogte en duur van het anesthetisch en motorisch blok met prilotekal bij verschillende doseringen
    E.2.2Secondary objectives of the trial
    duration to first voiding postoperatively, quality of per- and postoperative analgesia and patient satisfaction
    informatie te krijgen over moment tot eerste mictie, per en postoperatieve analgesie en patienttevredenheid
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients 18 year and older planned for spinal anesthesie in day case surgery
    patienten van 18 jaar en ouder gepland voor spinaal anesthesie in dagchirurgie
    E.4Principal exclusion criteria
    pregnancy
    allergy to prilocaine
    zwangerschap
    allergie voor prilocaine
    E.5 End points
    E.5.1Primary end point(s)
    Maximum block height (sensibility and motor)
    Time of regression to T10, L1 and S2 (sensibility)
    Time of regression of motor block
    Time to spontaneous urination or catherisation
    bereikte maximale blokhoogte en uitbreiding motorisch blok
    tijd tot regressie van blok tot T10, L1 en S2
    tijd tot verdwijnen motorisch blok
    tijdstip tot spontane mictie of catheterisatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. height of the anesthetic block (sensibility and motor) every 5 minutes up till incision.
    2. As far as possible during surgery every 15 minutes

    3. height of the anesthetic block (sensibility and motor) on arrival in the recovery room and then every 15 minutes
    4.height of the anesthetic block (sensibility and motor) on the ward every 30 minutes until discharge or complete resolution of block
    5. voiding based on patient report or urinary catheterization
    1.De blokhoogte iedere 5 min tot incisie, de mate van motorisch blok tot incisie.
    2. Voor zover praktisch uitvoerbaar zal peroperatief de blokhoogte bij iedere 15 minuten worden gecontroleerd.
    3. De blokhoogte en de mate van motorisch blok bij aankomst op de verkoever en vervolgens iedere 15 minuten.
    4. Op de afdeling is het streven dit minimaal iedere 30 minuten te
    registreren tot ontslag.
    5. tijdstip eerste mictie volgens opgave patient of catheterisatie
    E.5.2Secondary end point(s)
    the amount of fluid infused during and after surgery and the amount of fluids taken postoperatively
    bladder volume pre and postoperatively and at discharge if the patient did not urinate yet
    time of first urine production. If the patient does not urinate during admission, he/she will be asked to record the time at home
    bladder catheterisation if necessary and volume
    additional analgesics per and postoperatively
    use of vasopressors
    patient satisfaction with the procedure
    time of discharge, night admission if necessary and reason for night admission
    De vochtinname in de 6u voor de ingreep
    5. De hoeveelheid infusie per en postoperatief en de vochtinname postoperatief.
    6. de blaasinhoud pre en postoperatief en bij ontslag indien er nog geen mictie heeft plaatsgevonden.
    7. het tijdstip van eerste mictie. Indien de patient voor ontslag nog een mictie heeft gehad wordt hij/zij verzocht het tijdstip te noteren.
    8. blaascatheterisatie indien nodig en het urinevolume bij die catheterisatie
    9. toegediende analgetica per en postoperatief
    10. tevredenheid van de patient over de procedure.
    11. ontslagtijdstip, evt nachtopname en reden voor de opname
    E.5.2.1Timepoint(s) of evaluation of this end point
    during admission in day care
    gedurende opname in dagbehandeling
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    andere dosis
    different dose
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    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) 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: 30
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state130
    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 Decision2016-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-31
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