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    Summary
    EudraCT Number:2022-002321-10
    Sponsor's Protocol Code Number:PR11/2022
    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:2022-08-22
    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 number2022-002321-10
    A.3Full title of the trial
    Effectiveness and safety of topical sevoflurane for the treatment of painful skin ulcers; randomized, double-blind, placebo-controlled clinical trial
    Efectividad y seguridad del sevoflurano tópico para el tratamiento de úlceras cutáneas dolorosas; ensayo clínico aleatorizado, doble ciego controlado con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effectiveness and safety of the use of the drug sevoflurane for the treatment of painful skin ulcers
    Estudio de la fectividad y seguridad del uso del fármaco sevoflurano para el tratamiento de ´´ulceras cutáneas dolorosas
    A.3.2Name or abbreviated title of the trial where available
    Topical sevoflurane as a treatment for painful skin ulcers
    Sevoflurano tópico como tratamiento para úlceras cutáneas dolorosas
    A.4.1Sponsor's protocol code numberPR11/2022
    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 Universitari d'Igualada
    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 Universitari d'Igualada
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Igualada
    B.5.2Functional name of contact pointAnestesiología y Reanimación
    B.5.3 Address:
    B.5.3.1Street AddressAv Catalunya 11
    B.5.3.2Town/ cityIgualada
    B.5.3.3Post code08700
    B.5.3.4CountrySpain
    B.5.4Telephone number34938075500
    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 SEVORANE 100% LIQUIDO PARA INHALACION DEL VAPOR
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE SPAIN, S.L.U.
    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 nameSEVORANE 100% LIQUIDO PARA INHALACION DEL VAPOR
    D.3.2Product code 28523-86-6
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Topical
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSevoflurane
    D.3.9.1CAS number 28523-86-6
    D.3.9.3Other descriptive nameSevoflurane
    D.3.9.4EV Substance CodeSUB10506MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboTopical
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cutaneous complex ulcers (grade II, III and IV) which are painful and require hospital care
    Úlceras complejas (grados II-IV) dolorosas que precisen curas hospitalarias
    E.1.1.1Medical condition in easily understood language
    Cutaneous complex ulcers that are painful
    Úlceras cutáneas complejas dolorosas
    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 10065043
    E.1.2Term CMV mucocutaneous ulcer
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10045334
    E.1.2Term Ulcer skin
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016980
    E.1.2Term Foot ulcer
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077779
    E.1.2Term Pressure ulcer
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10077409
    E.1.2Term Ischemic skin ulcer
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine if people who receive sevoflurane during the treatment of complex skin ulcers have less pain than those who do not receive it.
    Determinar si los pacientes que reciben sevoflurano durante el tratamiento de las úlceras cutáneas complejas presentan menor dolor que los que no lo reciben.
    E.2.2Secondary objectives of the trial
    A) Determine if patients who receive sevoflurane during the treatment of complex skin ulcers have better epithelialization of the ulcers than the control group.

    B) Determine whether patients receiving sevoflurane during the treatment of complex skin ulcers have less infection of the ulcers than the control group.

    C) Determine whether patients receiving sevoflurane during the treatment of complex skin ulcers have less adverse events (pain, burning, itching, functional impotence, etc.) than those in the control group.
    A) Determinar si los pacientes que reciben sevoflurano durante el tratamiento de las úlceras cutáneas complejas presenta mejor epitelización de las úlceras que el grupo control.

    B) Determinar si los pacientes que reciben sevoflurano durante el tratamiento de las úlceras cutáneas complejas presentan menor sobreinfección de las úlceras que el grupo control.

    C) Determinar si los pacientes que reciben sevoflurano durante el tratamiento de las úlceras cutáneas complejas presentan menor número de efectos adversos (dolor, escozor, prurito, impotencia funcional, etc.) que los del grupo control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients with painful complex ulcers (grades II, III and IV) that require hospital care and who agree to participate in the study.
    Pacientes mayores de edad que presenten úlceras complejas (grados II, III y IV) dolorosas que precisen curas hospitalarias y que acepten participar en el estudio.
    E.4Principal exclusion criteria
    − Ulcers grade I or II with no continuity solution
    − History of allergy to halogenated gases
    − Personal or family history of malignant hyperthermia
    − Pregnancy
    − Difficulty to understand the informed consent (language barrier, cognitive deficit, etc.)
    − Úlceras grado I o grado II sin solución de continuidad
    − Antecedente de alergia a los gases halogenados
    − Antecedente personal o familiar de hipertermia maligna
    − Embarazo
    − Dificultad para comprender el consentimiento (barrera idiomática, déficit cognitivo, etc.)
    E.5 End points
    E.5.1Primary end point(s)
    Determine if there is a decrease/absence of pain after sevoflurane administration. Pain is measured according to the Numerical Rating Scale (EVN 1-10) during the ulcer healing procedure, just after applying the drug or placebo to the wound. The results will be recorded in a questionnaire correctly labeled with the identification code of each patient. A difference of 2 points from EVN is considered significant; we consider an EVN<3 as absence of pain.
    Determinar si existe disminución/ausencia de dolor de las úlceras tras la administración de sevoflurano. El dolor se mide según la Escala de Valoración Numérica (EVN 1-10) durante el procedimiento de cura de las úlceras, justo después de haber aplicado fármaco o placebo sobre la herida. Los resultados se anotarán en un cuestionario correctamente etiquetado con el código de identificación de cada paciente. Una diferencia de 2 puntos de EVN se considera significativa; hablamos de ausencia de dolor cuando EVN<3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pain is measured according to the Numerical Rating Scale (EVN 1-10) during the ulcer healing procedure, just after applying the drug or placebo to the wound.
    El dolor se mide según la Escala de Valoración Numérica (EVN 1-10) durante el procedimiento de cura de las úlceras, justo después de haber aplicado fármaco o placebo sobre la herida.
    E.5.2Secondary end point(s)
    A) Epithelialization (cm2).
    To determine if there is an improvement in the epithelialization of the wound after the administration of sevoflurane. Epithelialization is assessed before each treatment by calculating the area of ​​the ulcer in cm2 according to the Kundin method: A = L1 * L2 * 0.785 (where L1 is the largest diameter, L2 is the smallest diameter and 0.785 is the correction factor) . We speak of 'healing' when total epithelialization of the ulcer is achieved and 'partial healing' when the area of ​​the ulcer is reduced by 50%. All injuries will be photographed and digitized along with their corresponding questionnaire. The labeling will include the date and the identification code assigned to each patient.

    B) Superinfection.
    To determine if there is less superinfection of the wound in patients treated with sevoflurane. Superinfection of the wound will be determined by cultures -bacteriological, fungal and MRSA- in the presence of signs and symptoms suggestive of superinfection described by Restrepo JC, 2012 (28): increased pain, erythema, edema, increased temperature, increased of the exudate, purulent exudate, friable tissue, lack of healing progress, appearance of tissue compatible with biofilm, malodour, hypergranulation, increase in lesion size, appearance of satellite lesions and/or pallor. Cultures will be taken during the healing process of the injury. The results will be digitized and attached to the documentation for each patient, correctly labeled with the corresponding identification code and the date.

    C) Adverse effects (etiology, severity and recovery).
    To determine if there are any adverse effects (skin redness, itching, others) secondary to the administration of topical sevoflurane. At the end of each visit, a record will be made of the possible side effects that have appeared. These will be recorded in the questionnaire for each patient. In addition, a telephone number will be provided so that late-onset side effects can be reported.
    Adverse effects (AE) will be classified according to their etiology, severity and degree of recovery.
    Depending on their severity, adverse effects can be considered as:
    - Mild: Transient symptoms, without interference with the patient's daily activities (example: itching, redness of the wound margins, dizziness).
    - Moderate: Marked symptoms, moderate interference with the patient's daily activities (example: pain, worsening of the injury).
    - Serious: Considerable interference with the daily activities of the patient (example: intoxication, anaphylactic reaction, teratogenic reaction).
    The degree of recovery achieved can be:
    - Recovered without sequelae (fully recovered or the state has returned to the level observed at the initial level)
    - Recovered with sequelae (as a result of the AE, the patient suffers from persistent and significant disability/disability)
    - Improved, but not yet recovered
    - Still in progress (not recovered)
    - Death
    - Unknown

    D) Health-related quality of life (EQ-5D-5L).
    To determine the quality of life related to health (HRQoL) using the generic and standardized questionnaire EQ-5D-5L, formulated to make comparisons of the health of groups of patients and for the follow-up of patients after interventions. The EQ-5D-5L instrument consists of 2 parts: the EQ-5D-5L descriptive system and the Visual Analogue Scale (VAS).
    - The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of these dimensions has five possible responses or severity levels: no problems (1), minor problems (2), moderate problems (3), serious problems (4), and extreme problems/impossibility (5). Each interviewee indicates the level that best reflects their status for each of the five dimensions, so that their health status is described by five digits that take values ​​from 1 to 5, with health status 11111 considered a priori the best health status. health and 55555 the worst state of health.
    - In the VAS, the individual scores their health between two extremes, 0 and 100, the worst and best state of health imaginable.

    E) Variables sociodemográficas.
    Sexo, edad, peso, altura, estado civil, comorbilidades (diabetes, hipertensión, tabaquismo, insuficiencia venosa crónica, etc.), capacidad funcional (METs*), entorno familiar (vive solo/acompañado).
    *La capacidad funcional se define con los niveles de equivalentes metabólicos. 1 MET equivale al consumo de oxígeno (mL) por minuto que genera cada kg de peso en reposo: 1MET = consumo O2 (mL) / min / Kg de peso en reposo.
    A) Epitelización (cm2).
    Determinar si existe mejoría en la epitelización de la herida tras la administración de sevoflurano. La epitelización se valora antes de cada cura calculando el área de la úlcera en cm2 según el método de Kundin: A = L1 * L2 * 0.785 (donde L1 es el diámetro mayor, L2 es el diámetro menor y 0.785 es el factor de corrección). Hablamos de ‘curación’ cuando se consigue la epitelización total de la úlcera y de ‘curación parcial’ cuando el área de la úlcera se reduce un 50%. Todas las lesiones serán fotografiadas y digitalizadas junto con su correspondiente cuestionario. En el etiquetado constará la fecha y el código de identificación que se le haya asignado a cada paciente.

    B) Sobreinfección.
    Determinar si existe menor sobreinfección de la herida en los pacientes tratados con de sevoflurano. La sobreinfección de la herida se determinará mediante cultivos -bacteriológico, fúngico y MRSA- ante la presencia de signos y síntomas sugestivos de sobreinfección que describe Restrepo JC, 2012 (28): aumento del dolor, eritema, edema, aumento de la temperatura, aumento del exudado, exudado purulento, tejido friable, falta de progreso en la curación, aparición de tejido compatible con biofilm, mal olor, hipergranulación, aumento del tamaño de la lesión, aparición de lesiones satélite y/o palidez. La toma de cultivos se realizará durante el proceso de curación de la lesión. Los resultados se digitalizarán y se adjuntarán con la documentación de cada paciente correctamente etiquetada con el código de identificación correspondiente y la fecha.

    C) Efectos adversos (etiología, gravedad y recuperación).
    Determinar si existen efectos adversos (enrojecimiento cutáneo, escozor, otros) secundarios a la administración de sevoflurano tópico. Al final de cada visita se llevará a cabo un registro de los posibles efectos secundarios que hayan aparecido. Estos quedarán registrados en el cuestionario de cada paciente. Además, se facilitará un número de teléfono para que se puedan reportar aquellos efectos secundarios de aparición más tardía.
    Los efectos adversos (EA) serán clasificados según su etiología, gravedad y grado de recuperación.
    Según su gravedad, los efectos adversos pueden ser considerados como:
    - Leve: Síntomas transitorios, sin interferencia con las actividades diarias del paciente (ejemplo: escozor, enrojecimiento de los márgenes de la herida, mareo).
    - Moderado: Síntomas marcados, interferencia moderada con las actividades diarias del paciente (ejemplo: dolor, empeoramiento de la lesión).
    - Grave: Interferencia considerable con las actividades diarias del paciente (ejemplo: intoxicación, reacción anafiláctica, reacción teratógena).
    El grado de recuperación logrado puede ser:
    - Recuperado sin secuelas (totalmente recuperado o el estado ha vuelto al nivel observado en el nivel inicial)
    - Recuperado con secuelas (como resultado del EA, el paciente padece discapacidad / incapacidad persistente y significativa)
    - Mejorado, pero aún no recuperado
    - Todavía en curso (no recuperado)
    - Muerte
    - Desconocido

    D) Calidad de vida relacionada con la salud (EQ-5D-5L).
    Determinar la calidad de vida relacionada con la salud (CVRS) mediante el cuestionario genérico y estandarizado EQ-5D-5L, formulado para realizar comparaciones de la salud de grupos de pacientes y para el seguimiento de los pacientes tras las intervenciones. El instrumento EQ-5D-5L consta de 2 partes: el sistema descriptivo EQ-5D-5L y la Escala Visual Analógica (EVA).
    - El sistema descriptivo EQ-5D comprende 5 dimensiones: movilidad, autocuidado, actividades habituales, dolor/malestar y ansiedad/depresión. Cada una de estas dimensiones tiene cinco respuestas posibles o niveles de gravedad: sin problemas (1), problemas leves (2), problemas moderados (3), problemas graves (4) y problemas extremos/imposibilidad (5). Cada entrevistado señala el nivel que mejor refleja su estado para cada una de las cinco dimensiones con lo que su estado de salud queda descrito por cinco dígitos que toman valores del 1 al 5, siendo el estado de salud 11111 considerado a priori el mejor estado de salud y el 55555 el peor estado de salud.
    - En la EVA el individuo puntúa su salud entre dos extremos, 0 y 100, peor y mejor estado de salud imaginables.

    E) Variables sociodemográficas.
    Sexo, edad, peso, altura, estado civil, comorbilidades (diabetes, hipertensión, tabaquismo, insuficiencia venosa crónica, etc.), capacidad funcional (METs*), entorno familiar (vive solo/acompañado).
    *La capacidad funcional se define con los niveles de equivalentes metabólicos. 1 MET equivale al consumo de oxígeno (mL) por minuto que genera cada kg de peso en reposo: 1MET = consumo O2 (mL) / min / Kg de peso en reposo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A) Epithelialization is assessed before each dressing by calculating the area of ​​the ulcer.
    B) Superinfection of the wound will be determined by cultures in the presence of signs and symptoms suggestive of superinfection. Cultures will be taken during the healing process of the injury.
    C) At the end of each visit, a record of the possible secondary effects that have appeared will be carried out. In addition, a telephone number will be provided so that late-onset side effects can be reported.
    D) Health-related quality of life (EQ-5D-5L). The generic and standardized questionnaire EQ-5D-5L will be carried out at the first and last visit.
    E) Sociodemographic variables will be recorded during the first visit.
    A) La epitelización se valora antes de cada cura calculando el área de la úlcera.
    B) La sobreinfección de la herida se determinará mediante cultivos ante la presencia de signos y síntomas sugestivos de sobreinfección. La toma de cultivos se realizará durante el proceso de curación de la lesión.
    C) Al final de cada visita se llevará a cabo un registro de los posibles efectos secundarios que hayan aparecido. Además, se facilitará un número de teléfono para que se puedan reportar aquellos efectos secundarios de aparición más tardía.
    D) Calidad de vida relacionada con la salud (EQ-5D-5L). El cuestionario genérico y estandarizado EQ-5D-5L se realizará en la primera y la última visita.
    E) Las variables sociodemográficas se registrarán durante la primera visita.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    The follow-up period will be 1 month for each patient. This can be shortened in case of:
    - Completion of treatment (healed ulcer with 100% epithelialization)
    - Extent of grade I or grade II ulcer with no break in continuity
    - Serious adverse reaction
    - Will of the patient
    El período de seguimiento será de 1 mes para cada paciente. Éste puede acortarse en caso de:
    - Finalización del tratamiento (úlcera curada con epitelización del 100%)
    - Alcance de úlcera de grado I o grado II sin solución de continuidad
    - Reacción adversa grave
    - Voluntad del paciente
    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 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: 58
    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 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 state158
    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
    No
    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 Decision2023-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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