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    Summary
    EudraCT Number:2016-004117-27
    Sponsor's Protocol Code Number:QUEPRO
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-004117-27
    A.3Full title of the trial
    CONTROLLED, DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL FOR PROPHILAXIS OF POSOPERATIVE DELIRIUM IN HIGH RISK SURGICAL PATIENTS WITH QUETIAPINE.
    ENSAYO CLÍNICO CONTROLADO, DOBLE CIEGO Y ALEATORIZADO PARA LA PROFILAXIS CON QUETIAPINA DEL DELIRIO POSTOPERATORIO EN PACIENTES QUIRÚRGICOS DE RIESGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CONTROLLED, DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL FOR PROPHILAXIS OF POSOPERATIVE DELIRIUM IN HIGH RISK SURGICAL PATIENTS WITH QUETIAPINE.
    ENSAYO CLÍNICO CONTROLADO, DOBLE CIEGO Y ALEATORIZADO PARA LA PROFILAXIS CON QUETIAPINA DEL DELIRIO POSTOPERATORIO EN PACIENTES QUIRÚRGICOS DE RIESGO
    A.3.2Name or abbreviated title of the trial where available
    QUEPRO
    A.4.1Sponsor's protocol code numberQUEPRO
    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 SponsorIBSAL (Instituto de Investigación Biomédica de
    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 supportIBSAL
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportGRUPO DE RECUPERACION MULTIMODAL ESPAÑOL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIBSAL
    B.5.2Functional name of contact pointunidad de ensayos clínicos
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de San Vicente, 58-182
    B.5.3.2Town/ citySalamanca
    B.5.3.3Post code37007
    B.5.3.4CountrySpain
    B.5.4Telephone number34923210960
    B.5.5Fax number34923090472
    B.5.6E-mailensayosclinicos@ibsal.es
    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 Quetiapina NORMON 25 mg comprimidos recubiertos con peícula EFG
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON 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.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuetiapine fumarate
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.9.4EV Substance CodeSUB15074MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative delirium in high risk surgical patients.
    Delirio postoperatorio en pacientes quirúrgicos de alto riesgo.
    E.1.1.1Medical condition in easily understood language
    Postoperative delirium.
    Delirio postoperatorio.
    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
    To Know the incidence of postoperative delirium in patients at risk, over 65 years, treated early with prophylactic quetiapine versus placebo.
    Conocer la incidencia de delirio postoperatorio en pacientes de riesgo, mayores de 65 años, tratados precozmente con quetiapina profiláctica frente a los tratados con placebo.
    E.2.2Secondary objectives of the trial
    - Evaluate the safety and tolerability of the medication applied.
    - Compare the efficacy of medication versus placebo in relation to:
    the length of hospital stay.
    perceived quality of life.
    mortality (all causes) at discharge and at 28 ± 2 days from the start (first dose) of treatment with quetiapine.
    - In case of posoperative delirium , know:
    time of appearance
    the duration and severity.
    total dose of treatment with other antipsychotics.
    ‐ evaluar la seguridad y tolerabilidad de la medicación aplicada.
    ‐ comparar la eficacia de la medicación frente a placebo en relación a:
    la duración de la estancia hospitalaria.
    la calidad de vida percibida.
    la mortalidad por todas las causas al alta y a los 28±2 días desde el inicio (1º dosis) del tratamiento con quetiapina.
    ‐ En casos en los que se desarrolle delirio, conocer:
    momento de aparición
    la duración y severidad del mismo.
    dosis total de tratamiento con otros antipsicóticos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Greater than or equal to 65 years-old patients who will be undergoing major surgery (noncardiac) and having an equal or greater score of 7 on the scale Delphi:
    - Age: 70-79 years: 1 point; ≥80 years: 2 points
    - Physical activity: need for assistance, not self-sufficient: 1 point
    - Alcoholism: 1 point
    - Hearing Impaired: 1 point
    -History of delirium: 2 points
    - Emergency surgery: 1 point
    - No laparoscopic surgery: 2 points
    - Admission critical Units: 3 points
    - Value of C-reactive protein (CRP)> 10 mg / dL: 1 point
    Pacientes mayores o iguales a 65 años que va a ser sometido a cirugía mayor no
    cardiaca y que presenta una puntuación igual o mayor de 7 en la escala Delphi:
    - Edad: 70-79 años: 1 punto; ≥80 años: 2 puntos
    - Actividad física: necesidad de asistencia, no autosuficiente: 1 punto
    - Alcoholismo: 1 punto
    - Déficit auditivo: 1 punto
    - Antecedente de delirio: 2 puntos
    - Cirugía urgente: 1 punto
    - Cirugía no laparoscópica: 2 puntos
    - Admisión en Unidades de críticos: 3 puntos
    - Valor de Proteina C Reactiva (PCR) > 10 mg/dL: 1 punto
    E.4Principal exclusion criteria
    - Allergy to quetiapine.
    - Patients at low risk of developing delirium at admission.
    - Diagnosis of delirium at admission.
    - Cardiological diseases: qtc > 460mseg in men, > 470 msec in women, recent MI or cardiac decompensation, 2-3 ° AV block or history of torsades de pointes arrhythmias or ventricular arrhythmias, bradycardia...
    - Hypokalemia <3 mEq / CLK.
    - History of drug use.
    - Patients on Antipsychotic or antidopaminergic treatment (chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, paliperidone, amisulpride).
    - Parkinson's disease.
    - Test MINIMENTAL <24.
    - Corps or vascular dementia Levi.
    - Hypokinetic movement disorder.
    - History of neuroleptic malignant syndrome.
    - Central Anticholinergic Syndrome.
    - Epilepsy.
    - Patients with a wight less than 50 or greater than 200 kg.
    ‐ Alergia a quetiapina.
    ‐ Pacientes con bajo riesgo de desarrollar delirio al ingreso
    ‐ Diagnóstico de delirio al ingreso.
    ‐ Enfermedades cardiológicas: qtc >460mseg en hombres,>470 mseg en
    mujeres, IAM o descompensación cardiaca reciente, bloqueo AV 2-3º o
    antecedentes de arritmias tipo torsades de pointes o arritmias ventriculares,
    bradicardia.
    ‐ Hipopotasemia <3 meq/CLK.
    ‐ Historia de consumo de drogas.
    ‐ Pacientes en tratamiento antipsicótico o antidopaminérgico (clorpromacina,
    clozapina, olanzapina, risperidona, haloperidol, quetiapina, paliperidona,
    amisulpride).
    ‐ Enfermedad de Parkinson.
    ‐ Test MINIMENTAL <24.
    ‐ Demencia vascular o de Cuerpos de Levi.
    ‐ Desorden de movimientos hipocinéticos.
    ‐ Historia de Síndrome Neuroléptico Maligno.
    ‐ Síndrome Anticolinérgico Central.
    ‐ Epilepsia.
    ‐ Pacientes con un peso menor de 50 o mayor de 200 kg.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients diagnosed with delirium (number of cases of delirium / total number of patients) within the first four days in both arms.
    Proporción de pacientes diagnosticados de delirio (nº casos delirio/número total pacientes) en los 4 primeros días del postoperatorio en ambas ramas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 (± 2) days before the start of treatment in each patient.
    28 (± 2) días desde el comienzo del tratamiento en cada paciente.
    E.5.2Secondary end point(s)
    - Number of days from the start of treatment until delirium, if it appears.
    - Duration of delirium, in days.
    - Severity of delirium measured with a validated scale (DRS-R-98).
    - Total dose (mg) of other antipsychotic (haloperidol) to control symptoms of delirium.
    - Security variables:
    degree sedation: by RASS scale.
    QTc prolongation: increased msec ECG control.
    presence or absence of extrapyramidal symptoms (tremor, involuntary movements, rigidity).
    - Days in hospital from surgery.
    - Perceived quality of life (using validated questionnaire SF36) at 28 (± 2) days before the start of treatment
    - Mortality (all causes) at discharge and at 28 (± 2) days before the start of treatment.
    ‐ número de días desde el inicio de tratamiento hasta inicio de delirio, si aparece.
    ‐ duración del delirio, en días.
    ‐ severidad del delirio medida con escala validada (DRS-R-98).
    ‐ dosis total (mg) haloperidol u otro antipsicótico para control de los síntomas de
    delirio.
    ‐ variables de seguridad:
    grado sedación: mediante escala RASS.
    prolongación QTc: incremento en mseg en el ECG de control.
    presencia o ausencia de síntomas extrapiramidales (temblor, movimientos involuntarios, rigidez).
    ‐ días de estancia hospitalaria desde la intervención quirúrgica.
    ‐ calidad de vida percibida (mediante cuestionario validado SF36) a los 28(±2) días del inicio del tratamiento
    ‐ mortalidad por todas las causas al alta y a los 28(±2) días del inicio del tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 (± 2) days before the start of treatment in each patient.
    28 (± 2) días desde el comienzo del tratamiento en cada paciente.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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) No
    E.8.2.2Placebo Yes
    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 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
    Ultima visita del ultimo sujeto
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state350
    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)
    Patients will be follow up in National Heath System.
    Los pacientes serán seguidos en el Sistema Nacional de Salud.
    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 Decision2018-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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