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    Summary
    EudraCT Number:2022-002179-12
    Sponsor's Protocol Code Number:PRILODE50-FUSION
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-15
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-002179-12
    A.3Full title of the trial
    Determination of the effective dose 50 of intrathecal hyperbaric prilocaine required for the transrectal ultrasound guidance fusion-targeted prostate biopsy in ambulatory surgery
    Determinación de la dosis efectiva 50 de prilocaína hiperbárica intratecal requerida para la realización de la biopsia de próstata por fusión en cirugía ambulatoria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose of intraspinal prilocaina required for prostate biopsy
    Dosis de prilocaína intraraquídea necesaria para realizar la biopsia de próstata fusión en cirugía ambulatoria
    A.4.1Sponsor's protocol code numberPRILODE50-FUSION
    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 SponsorMatilde Zaballos
    B.1.3.4CountrySpain
    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 supportMAtilde Zaballos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMatilde Zaballos
    B.5.2Functional name of contact pointMatilde Zaballos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Doctor Esquerdo,46
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number+34657813987
    B.5.6E-mailmati@plagaro.net
    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 Takipril
    D.2.1.1.2Name of the Marketing Authorisation holderB. BRAUN MEDICAL, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 name70932
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrathecal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNprilocaine hydrochloride
    D.3.9.3Other descriptive namePrilocaine hydrochloride
    D.3.9.4EV Substance CodeSUB04038MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    anaesthesia for prostate fusion biopsy in outpatient surgery
    anestesia en realización de la biopsia de próstata por fusión en cirugía ambulatoria
    E.1.1.1Medical condition in easily understood language
    anaesthesia for prostate biopsy in outpatient surgery
    anestesia en realización de la biopsia de próstata en cirugía ambulatoria
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10004825
    E.1.2Term Biopsy of prostate
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect dose 50 of prilocaine required to perform prostate fusion biopsy in patients undergoing surgery at AMC.
    Determinar la dosis efecto 50 de prilocaína requerida para realizar la biopsia de próstata por fusión en pacientes intervenidos en CMA
    E.2.2Secondary objectives of the trial
    - To assess the evolution of sensory and motor block after spinal anaesthesia.
    - To analyse the haemodynamic response during surgery (hypotension and/or bradycardia).
    - To know the incidence of DAP in the immediate postoperative period in this procedure.
    - To know the incidence of acute urinary retention in the immediate postoperative period.
    - To know the incidence of postoperative nausea and vomiting (PONV).
    - To know the average length of stay in the AMC Unit.
    - To determine the causes of delayed discharge from the unit.
    - To determine the incidence of unplanned admissions and their causes.
    - Evaluar la evolución del bloqueo sensitivo y motor tras la anestesia espinal
    - Analizar la respuesta hemodinámica durante la cirugía (hipotensión y/o bradicardia).
    - Conocer la incidencia de DAP en el postoperatorio inmediato en este procedimiento
    - Conocer la incidencia de retención aguda de orina en el postoperatorio inmediato.
    - Conocer la incidencia de náuseas y vómitos (NVPO) en el postoperatorio
    - Conocer la estancia media en la Unidad de CMA.
    - Conocer las causas de retraso en el alta de la unidad.
    - Conocer la incidencia de ingresos no previstos y sus causas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -ASA I, ASA II and ASA III patients.
    - Aged 18-85 years,
    - Prostate fusion biopsy procedure
    - Signed informed consent
    -Pacientes ASA I, ASA II y ASA III.
    - Con edades entre 18-85 años,
    - Procedimiento de biopsia de próstata fusión
    - Firma del consentimiento informado
    E.4Principal exclusion criteria
    standard contraindications to neuraxial blockade, coagulopathy, site infection, neurological impairment, known allergy to local anaesthetics.
    contraindicaciones estándar al bloqueo neuraxial, coagulopatía, infección de la zona, el deterioro neurológico, alergia conocida a los anestésicos locales.
    E.5 End points
    E.5.1Primary end point(s)
    positive cold response in L1-L2
    respuesta positiva al frio en L1-L2
    E.5.1.1Timepoint(s) of evaluation of this end point
    intraoperative
    intraoperatorio
    E.5.2Secondary end point(s)
    hypotension and/or bradycardia
    sensory and motor block
    incidence of DAP
    incidence of acute urinary retention
    incidence of nausea and vomiting
    average length of stay in the AMC Unit
    causes of delayed discharge from the unit
    the incidence of unplanned admissions
    - - bloqueo sensitivo y motor
    - hipotensión y/o bradicardia.
    - incidencia de DAP
    - incidencia de retención aguda de orina
    -incidencia de náuseas y vómitos
    - estancia media en la Unidad de CMA.
    - causas de retraso en el alta de la unidad.
    - incidencia de ingresos no previstos y sus causas
    E.5.2.1Timepoint(s) of evaluation of this end point
    evolution of sensory and motor block after spinal anaesthesia.
    haemodynamic response during surgery (hypotension and/or bradycardia).
    incidence of DAP in the immediate postoperative period
    incidence of acute urinary retention in the immediate postoperative period.
    incidence of postoperative nausea and vomiting (PONV).
    average length of stay in the AMC Unit.
    evolución del bloqueo sensitivo y motor tras la anestesia espinal
    respuesta hemodinámica durante la cirugía (hipotensión y/o bradicardia).
    la incidencia de DAP en el postoperatorio inmediato
    incidencia de retención aguda de orina en el postoperatorio inmediato.
    incidencia de náuseas y vómitos (NVPO) en el postoperatorio
    estancia media en la Unidad de CMA.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 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(telephonic contact 24h after discharge)
    UVUP( contacto telefónico 24 horas despues del alta )
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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
    NINGUNO
    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 Decision2022-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
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