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    Summary
    EudraCT Number:2017-000692-92
    Sponsor's Protocol Code Number:MK-8616-089
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-17
    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 number2017-000692-92
    A.3Full title of the trial
    A Phase 4 Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants
    Ensayo clínico de fase 4, aleatorizado, doble ciego y controlado con comparador activo para estudiar la eficacia, la seguridad y la farmacocinética de sugammadex (MK-8616) para neutralizar el bloqueo neuromuscular en participantes pediátricos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PK, safety and efficacy of sugammadex in children 2 to <17 years of age
    Farmacocinética, seguridad y eficacia de sugammadex en niños de 2 a < 17 años
    A.3.2Name or abbreviated title of the trial where available
    PK, safety and efficacy of sugammadex in children 2 to <17 years of age
    Farmacocinética, seguridad y eficacia de sugammadex en niños de 2 a < 17 años
    A.4.1Sponsor's protocol code numberMK-8616-089
    A.5.4Other Identifiers
    Name:NCTNumber:03351608
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España SA
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.com
    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 Bridion (sugammadex injection)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSUGAMMADEX SODIUM
    D.3.9.1CAS number 343306-79-6
    D.3.9.2Current sponsor codeMK-8616
    D.3.9.3Other descriptive nameSUGAMMADEX SODIUM
    D.3.9.4EV Substance CodeSUB32205
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(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.IMP: 2
    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 NEOSTIG (neostigmine methylsulfate injection)
    D.2.1.1.2Name of the Marketing Authorisation holderCarinopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEOSTIGMINE METHYLSULFATE
    D.3.9.3Other descriptive nameNEOSTIGMINE METHYLSULFATE
    D.3.9.4EV Substance CodeSUB20700
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 3
    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 Robinul (Glycopyrrolate Injection)
    D.2.1.1.2Name of the Marketing Authorisation holderRIEMSER Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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: 4
    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 Atropine sulphate injection
    D.2.1.1.2Name of the Marketing Authorisation holderMartindale Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATROPINE SULFATE
    D.3.9.1CAS number 55-48-1
    D.3.9.4EV Substance CodeSUB00625MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    Reversal of neuromuscular blockade (NMB)
    Neutralización del bloqueo neuromuscular (BNM).
    E.1.1.1Medical condition in easily understood language
    Reversal of neuromuscular blockade in participants undergoing surgery or medical procedure
    Reversor del bloqueo neuromuscular en pacientes sometidos a una cirugía o a un procedimiento médico.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018061
    E.1.2Term General 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
    1. To describe the pharmacokinetic parameters of sugammadex when used for reversal of moderate NMB or deep NMB (Part A)
    2. To evaluate safety and tolerability of sugammadex (data will be pooled across Part A and Part B of the study)
    3. To evaluate the efficacy of sugammadex in comparison to neostigmine for the reversal of moderate NMB (Part B)
    1. Describir los parámetros farmacocinéticos de sugammadex cuando se utiliza para neutralizar un bloqueo neuromuscular (BNM) moderado o profundo (parte A).
    2. Evaluar la seguridad y la tolerabilidad de sugammadex (se agruparán los datos de las partes A y B del estudio).
    3. Evaluar la eficacia de sugammadex en comparación con neostigmina en la neutralización de un BNM moderado (parte B)
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of sugammadex in comparison to neostigmine for the reversal of moderate NMB (Part B)
    Evaluar la eficacia de sugammadex en comparación con neostigmina en la neutralización de un BNM moderado (parte B).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must be categorized as ASA Physical Status Class 1, 2, or 3, as determined by the investigator
    2. Have a planned non-emergent surgical procedure or clinical situation (eg, intubation) that requires moderate or deep NMB with either rocuronium or vecuronium
    3. Have a planned surgical procedure or clinical situation that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring
    4. Age between 2 to <17 years at Visit 2.
    5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a.) Not a woman of childbearing potential (WOCBP)
    OR
    b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment
    6. The participant (and/or legally acceptable representative, if applicable) provides written informed consent/assent for the trial
    1. Clasificación en la clase 1, 2 o 3 de estado físico según la ASA, según lo determinado por el investigador.
    2. Intervención quirúrgica o situación clínica (por ejemplo, intubación) no urgente programada que requiera un BNM moderado o profundo con rocuronio o vecuronio.
    3. Intervención quirúrgica o situación clínica programada que permita la aplicación de técnicas objetivas de monitorización neuromuscular con acceso al brazo para monitorizar la transmisión neuromuscular.
    4. Edad comprendida entre 2 y < 17 años en la visita 2.
    5. Una mujer podrá participar en el estudio si no está embarazada (véase el apéndice 5), no está amamantando y cumple al menos una de las condiciones siguientes:
    a.) No ser una mujer en edad fértil (MEF) según se define en el Apéndice 5.
    O
    b) Es una MEF que se compromete a seguir las normas relativas a métodos anticonceptivos indicadas en el apéndice 5 durante el período de tratamiento y hasta, como mínimo, 7 días después de la última dosis del tratamiento del estudio.
    6. El participante (y/o su representante legal cuando proceda) otorga su consentimiento/ asentimiento informado por escrito para el ensayo.
    E.4Principal exclusion criteria
    1. Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial
    2. Has a neuromuscular disorder that may affect NMB and/or trial assessments
    3. Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate (eGFR) <30 ml/min; using revised Schwartz estimate as method of calculation)
    4. Has or is suspected of having a family or personal history of malignant hyperthermia
    5. Has or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia
    6. Has received or is planned to receive toremifene and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment
    7. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
    8. Use of medication expected to interfere with study treatments given in this trial, as per prescribing information
    9. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial
    10. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial
    11. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
    1. Presencia de cualquier enfermedad o situación de importancia clínica (por ejemplo, malformación anatómica que complique la intubación) distinta de la enfermedad en estudio que, en opinión del investigador, podría interferir en las evaluaciones del ensayo o en la participación óptima en el ensayo.
    2. Presencia de un trastorno neuromuscular que podría afectar al BNM o a las evaluaciones del ensayo.
    3. Dependencia de diálisis o presencia (o sospecha) de una insuficiencia renal grave (definida como una filtración glomerular estimada (FGe) < 30 ml/min, utilizando la estimación de Schwartz revisada como método de cálculo).
    4. Presencia o sospecha de antecedentes familiares o personales de hipertermia maligna.
    5. Presencia o sospecha de alergia a los tratamientos del estudio o sus excipientes, a los opiáceos, a los relajantes musculares o sus excipientes o a otros medicamentos utilizados durante la anestesia general.
    6. Recepción o previsión de recibir toremifeno o ácido fusídico por vía IV en las 24 horas previas o las 24 horas siguientes a la administración del tratamiento del estudio.
    7. Mujer en edad fértil que da positivo en una prueba de embarazo en orina realizada en las 24 horas previas a la primera dosis del tratamiento del estudio (véase el apéndice 5). Cuando el resultado de la prueba en orina no pueda confirmarse que es negativo, será necesario hacer una prueba de embarazo en suero. En tal caso, la participante será excluida si el resultado de la prueba de embarazo en suero es positivo.
    Tratamiento previo y concomitante
    8. Uso de medicación que interferirá previsiblemente en los tratamientos del estudio administrados en este ensayo, de acuerdo con la ficha técnica.
    9. Tratamiento previo con sugammadex o participación en un ensayo clínico con sugammadex.
    10. Participación activa o previa en un ensayo clínico intervencionista con un fármaco o dispositivo experimental en los 30 días previos a la firma del consentimiento/asentimiento informado para el presente ensayo.
    11. El participante o un familiar directo (por ejemplo, cónyuge, padre/madre o tutor legal, hermano o hijo) forman parte del personal del centro de investigación o del promotor implicado directamente en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Part A only- Pharmacokinetic: Area under the plasma concentration-time curve (AUC), clearance (CL), volume of distribution (Vz), maximum plasma concentration (Cmax), and half-life (t1/2)
    2. Part A and Part B- Safety: Adverse event (AE) reporting, laboratory and vital sign assessments. Events of clinical interest: clinically relevant bradycardia, hypersensitivity and anaphylaxis.
    3. Part B only - Efficacy: The time to recovery to a train-of-four (TOF) ratio of ≥0.9
    1. Sólo parte A, farmacocinética: área bajo la curva de concentración-tiempo plasmática (ABC), aclaramiento (CL), volumen de distribución (Vd), máxima concentración de plasma (Cmax) y tiempo medio de vida de eliminación (t1/2)
    2. Parte A y Parte B, seguridad: Comunicación de Acontecimientos Adversos (AA), evaluaciones de laboratorio y de constantes vitales. Acontecimientos de Interés Clínico: bradicardia, hipersensibilidad y anafilaxis clínicamente relevantes.
    3. Sólo parte B, eficacia: el tiempo de recuperación en un ratio de ≥ 0.9 tren de cuatro (TOF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. PK samples collected at 2, 15, 30, 60 mi., 5 and 10 hours post-administration of study drug
    2. AEs reported throughout participation in the study (~ 28 days). Safety laboratory assessments at Day1 (peri-anesthetic period) and Day 1 to 2 (post-treatment). Vital signs assessments on Day 1: Prior to administration of NMBA; Prior to administration of study treatment; and 2, 5, 10 and 30 min. after study treatment.
    3. Neuromuscular monitoring will be performed using a TOF-Watch SX®. After induction of anesthesia, neuromuscular monitoring will start before the administration of neuromuscular blocking agent.

    Read in the protocol
    1. Las muestras de FC recogidas 2, 15, 30, 60 minutos y 5 y 10 horas después de la administración del fármaco del estudio
    2. Los AAs comunicados durante la participación en el estudio (˜ 28 días). Evaluaciones de seguridad realizadas en el laboratorio el día 1 (periodo peri anestésico) y de los días 1 a 2 (post tratamiento). Evaluación de las constantes vitales el día 1: antes de la administración de NMBA; antes de la administración del tratamiento del estudio y 2, 5, 10 y 30 minutos después del tratamiento del estudio.
    3. La monitorización neuromuscular se llevará a cabo utilizando un dispositivo TOF-Watch SX®. Después de la inducción de la anestesia, la monitorización neuromuscular empezará antes de la administración del agente bloqueador neuromuscular.

    Leer en el protocolo
    E.5.2Secondary end point(s)
    1. The time to recovery to a TOF ratio of ≥0.8
    2. The time to recovery to a TOF ratio of ≥0.7
    1. El tiempo de recuperación a un ratio TOF de ≥ 0.8
    2. El tiempo de recuperación a un ratio TOF de ≥ 0.7
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Neuromuscular monitoring will be performed using a TOF-Watch SX®. After induction of anesthesia, neuromuscular monitoring will start before the administration of neuromuscular blocking agent. Neuromuscular monitoring should remain ongoing until the participant reaches the endpoint of TOF ratio ≥0.8, or for at least 30 minutes following administration of a single dose of study drug.
    2. Neuromuscular monitoring will be performed using a TOF-Watch SX®. After induction of anesthesia, neuromuscular monitoring will start before the administration of neuromuscular blocking agent.

    Read in the protocol
    1. La monitorización neuromuscular se llevará a cabo utilizando un dispositivo TOF-Watch SX®. Después de la inducción de la anestesia, la monitorización neuromuscular empezará antes de la administración del agente bloqueador neuromuscular. La monitorización neuromuscular permanecerá en marcha hasta que el paciente llegue al objetivo de TOF ≥ 0.8, o durante al menos 30 minutos después de la administración de una dosis única del fármaco del estudio.
    2. La monitorización neuromuscular se llevará a cabo utilizando un dispositivo TOF-Watch SX®. Después de la inducción de la anestesia, la monitorización neuromuscular empezará antes de la administración del agente bloqueador neuromuscular.

    Leer en el Protocolo
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Denmark
    Finland
    Germany
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 238
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 170
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 68
    F.1.2Adults (18-64 years) No
    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 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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 238
    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 Decision2018-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
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