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    Summary
    EudraCT Number:2019-002428-34
    Sponsor's Protocol Code Number:ANE-DEX-2019
    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:2019-07-04
    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 number2019-002428-34
    A.3Full title of the trial
    ONE CENTRE, DOUBLE BLIND, ONE CENTRE, RANDOMIZED CLINICAL TRIAL, IN TWO PARALLEL GROUPS TO EVALUATE THE EFICACY IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING OF DEXAMETHASONE VERSUS METHILPREDNISOLONE IN NOT URGENT LAPAROSCOPIC CHOLECYSTECTOMY
    ENSAYO CLÍNICO UNICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO, EN DOS GRUPOS PARALELOS, PARA EVALUAR EFICACIA EN LA PREVENCIÓN DE LA NAUSEA Y VÓMITO POSTOPERATORIOS DE DEXAMETASONA FRENTE METILPREDNISOLONA EN CIRUGÍA DE COLECISTECTOMÍA LAPAROSCÓPICA NO URGENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO EVALUATE THE EFICACY OF DEXAMETHASONE VERSUS METHILPREDNISOLONE IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN NOT UNGENT LAPAROSCOPY CHOLECISTECTOMY
    ENSAYO CLÍNICO PARA EVALUAR DEXAMETASONA VERSUS METILPREDNISOLONA EN LA PREVENCIÓN DE NAUSEA Y VÓMITO POSTOPERTATORIO TRAS COLECISTECTOMIA NO URGENTE
    A.4.1Sponsor's protocol code numberANE-DEX-2019
    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 SponsorHOSPITAL CLINICO SAN CARLOS
    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 supportHOSPITAL CLINICO SAN CARLOS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL CLINICO SAN CARLOS
    B.5.2Functional name of contact pointServicio de Anestesia y Reanimación
    B.5.3 Address:
    B.5.3.1Street AddressC/MARTIN LAGOS S/N
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913303040
    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 Fortecortin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, S.L.
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.1CAS number C22H29FO5
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.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 Urbason
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS, 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 Solution for injection/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 INNMETHYLPREDNISOLONE
    D.3.9.1CAS number C22H30O5
    D.3.9.4EV Substance CodeSUB08872MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Postoperative nausea and vomiting after not urgent laparoscopic cholecystectomy
    Nausea y vómito postoperatorio tras colecistectomia no urgente
    E.1.1.1Medical condition in easily understood language
    Postoperative nausea and vomiting after not urgent laparoscopic cholecystectomy
    Nausea y vómito postoperatorio tras colecistectomia no urgente
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036901
    E.1.2Term Prophylaxis against postoperative nausea and vomiting
    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
    The main objective of the trial is to compare the eficacy of dexamethasone vs. methylprednisolone in the prevention of postoperative nausea and vomiting the firt 24 hours after nor urgent laparoscopic cholecistectomy
    El objetivo principal en comparar la eficacia de dexametasona vs. metilprednisolona en la prevención de nausea y vómito postopratorio las primeras 24h tras colecistectomia no urgente
    E.2.2Secondary objectives of the trial
    Secondary objetives are the follow:
    To know the incidence of postoperative nausea and vomiting in the first two hours after surgery and from hour two to hour 24
    To investigate diferencies in postopertive pain during the first 24 hours after surgery
    To measure and compare glucose levels in both groups at hour 2 and 24 after surgery
    To know rates of surgical site infection during hospital stay
    Grade of patient satisfaction related to nausea and vomiting in the first 24 hours after surgery
    Conocer la incidencia de nausea y vómito postoperatorio en las dos primers hos tras la cirugía y desde la hora 2 a la 24
    Diferencias en el dolor postoperatorio en las primeras 24 h
    Medir y comparar los niveles de glucosa en la hora 2 y 24 del postoperatorio
    Incidencias de infección del sitio quirúrgico durante la estancia hospitalaria
    Grado de satisfacción delpaciente en relación con la nausea y vómito postoperatorio en las primeras 24 h tras cirugía
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients over 18 years old, candidates to laparoscopic cholecystectomy.
    The patients must be well informed of the study and must voluntary accept to colaborate, obteining his/her consent
    Paciente mayores de 18 años, candidatos a colecistectomía no urgente.
    Los pacientes deben estar bien informados del estudio y deben aceptar voluntariamente su participación, obteniendo su consentimiento
    E.4Principal exclusion criteria
    - Patients whith any allergy or intolerance to any of the drugs used in the study
    - Patients whith medical history of postoperative nausea and vomiting or motion sickness
    - Pstient who refuse to participate in the study
    - Patients with personal or familiar history of malignant hypertermia
    - Pacients under 18 yeras old.
    - Pacients with chronic trestment with opioids, antiemetic drugs or corticoids
    - Pacients who have taken psicoactive drugs or antihistamine medicines the 24 hours before the surgery
    - Pacients anable to give informed consent
    Pacientes con alergia a alguno de los fármacos utilizados
    Pacientes con historia de nausea o vómitos o cinetosis
    Pacientes que no quieran participar en el estudio
    Pacientes menores de 18 años
    pacientes con tratamiento cronico con opioides, fármacos antieméticos o corticoides
    Pacientes que hayan tomado fármacos psicoactivos o antihistamínicos en las 24h previas a la cirugía
    Pacientes incapaces de dar su consentimiento
    E.5 End points
    E.5.1Primary end point(s)
    At least 14% decrease in postoperative nausea and vomiting in the group who recive methylprednisole versus dexametasone
    Al menos 14% de disminución de nausea y vómito entre cada grupo de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 24 hours after surgery divided in the first 2 hours and from hour 2 to 24
    Las primeras 24h tras la cirugía divididas en las 2 primeras y desde la 2 a la 24
    E.5.2Secondary end point(s)
    Reduction in pain visual analogue scale of at least 2 points
    No differences in surgical site infection rates
    No differences in glucose levels
    Reducción en la escala visual analógica de dolor en 2 puntos
    No diferencias en incidencia de infección de herida quirúrgica
    No diferencias en niveles de glucosa
    E.5.2.1Timepoint(s) of evaluation of this end point
    First 24 hours after surgery
    Primeras 24 h tras cirugía
    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 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 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 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 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 years1
    E.8.9.1In the Member State concerned months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 state314
    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
    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 Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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