Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35654   clinical trials with a EudraCT protocol, of which   5853   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-001412-30
    Sponsor's Protocol Code Number:FMLD-FEBETRADI-PILOT-43_FIII
    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:2018-05-21
    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 number2018-001412-30
    A.3Full title of the trial
    Double blind, randomized, pilot clinical trial controlled with placebo to evaluate the comparative efficacy of ibuprofen combined with different doses of tramadol and tramadol 100 mg by intravenous route in patients with moderate-intense pain after dental surgery.
    ENSAYO CLÍNICO, PILOTO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO PARA EVALUAR LA EFICACIA COMPARADA DE IBUPROFENO COMBINADO CON DIFERENTES DOSIS DE TRAMADOL Y TRAMADOL 100 MG POR
    VÍA INTRAVENOSA EN PACIENTES CON DOLOR MODERADO A INTENSO TRAS CIRUGÍA DENTAL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO EVALUATE THE EFFICACY OF IBUPROFEN COMBINED WITH DIFFERENT DOSES OF TRAMADOL AND TRAMADOL INTRAVENOUS AFTER DENTAL SURGERY
    ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA IBUPROFENO COMBINADO CON DIFERENTES DOSIS DE TRAMADOL Y TRAMADOL POR VÍA INTRAVENOSA PARA EL DOLOR TRAS CIRUGÍA DENTAL.
    A.3.2Name or abbreviated title of the trial where available
    FMLD-FEBETRADI-PILOT-43_FIII
    A.4.1Sponsor's protocol code numberFMLD-FEBETRADI-PILOT-43_FIII
    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 SponsorLaboratorios Farmalíder S.A.
    B.1.3.4CountrySpain
    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 supportLaboratorios Farmalíder S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Farmalíder S.A.
    B.5.2Functional name of contact pointDevelop and technical support
    B.5.3 Address:
    B.5.3.1Street AddressCalle La granja 1-3º
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number+34916612335
    B.5.5Fax number+34916610442
    B.5.6E-mailcarloscalandria@farmalider.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 No
    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 nameIbuprofen/tramadol
    D.3.4Pharmaceutical form Solution for 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 INNINN
    D.3.9.1CAS number 27203-92-5
    D.3.9.2Current sponsor codeTramadol
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.2Current sponsor codeIBUPROFEN
    D.3.9.3Other descriptive nameIBUPROFEN
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    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 nameIbuprofen/tramadol
    D.3.4Pharmaceutical form Solution for 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 INNINN
    D.3.9.1CAS number 27203-92-5
    D.3.9.2Current sponsor codeTramadol
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.2Current sponsor codeIBUPROFEN
    D.3.9.3Other descriptive nameIBUPROFEN
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Adolonta
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal Pharma, 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
    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 INNINN
    D.3.9.1CAS number 27203-92-5
    D.3.9.2Current sponsor codeadolonta
    D.3.9.3Other descriptive nameTRAMADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04927MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-Intense pain in Dental Surgery
    Dolor moderado-intenso en cirugía dental
    E.1.1.1Medical condition in easily understood language
    Moderate-Intense pain in Dental Surgery
    Dolor moderado-intenso en cirugía dental
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10044049
    E.1.2Term Dental pain and sensation disorders
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate in a preliminary way the analgesic efficacy measured by the Visual Analog Scale (VAS) 6 hour before administration of a single dose of the fixed-dose combination of ibuprofen (arginate) 400 mg with two dose of intravenous medication versus tramadol 100 mg IV, controlled with placebo.
    Evaluar de modo preliminar la eficacia analgésica medida por la Escala Visual Analógica (EVA) a las 6 horas de administrada una dosis única de la combinación a dosis fija de ibuprofeno (arginato) 400 mg con dos niveles de dosis de tramadol por vía intravenosa frente a tramadol 100 mg IV, controlado con placebo.
    E.2.2Secondary objectives of the trial
    To estimate the measure and variability of the analgesic effect of each of the ibuprofen combinations (arginate) and tramadol IV vs placebo.
    To estimate the measure and variability of the analgesic effect of tramadol 100 mg IV vs placebo.
    To evaluate the safety and tolerability of each medication or combination used in order to improve the patients safety.
    Estimar medida y variabilidad del efecto analgésico de cada una de las combinaciones de ibuprofeno (arginato) y tramadol IV vs placebo.
    Estimar medida y variabilidad del efecto analgésico de tramadol 100 mg IV vs placebo.
    Evaluar la seguridad y la tolerabilidad de cada una de las medicaciones o combinaciones empleadas, con el fin de mejorar el perfil de seguridad de los pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who give their informed consent in writing and are willing to comply with all the visits and scheduled procedures required by the protocol.
    2. Patients ≥ 18 years.
    3. Moderate-intense pain (SAV 0-100 ≥55 mm) during the first 4 hours after completing the surgery.
    4. With body weight> 50 and <110 kg.
    5. Scheduled for ambulatory surgical removal, under local anesthesia, of at least two third parties molars, at least one of them lower, and at least one of them impacted that requires elimination of bone.
    6. That they agree not to take analgesics except for those that the protocol defines as medication of rescue during the treatment period, until after 7 hours after the administration of the study medication.
    7. Have a medical history and physical examination without clinically relevant abnormalities in function of the study and at the discretion of the researcher
    1. Pacientes que otorguen su consentimiento informado por escrito y dispuestos a cumplir con todas las visitas y los procedimientos programados que requiere el protocolo.
    2. Pacientes ≥ 18 años.
    3. Con dolor moderado-intenso (EVA0-100 ≥55 mm) durante las primeras 4 horas tras finalizar la cirugía.
    4. Con peso corporal >50 y < 110 kg.
    5. Programados para la extracción quirúrgica ambulatoria, bajo anestesia local, de al menos dos terceros molares, al menos uno de ellos inferior, y al menos uno de ellos impactado que requiera eliminación de hueso.
    6. Que acepten no tomar analgésicos a excepción de los que el protocolo define como medicación de rescate durante el período de tratamiento, hasta pasadas 7 horas tras la administración de la medicación del estudio.
    7. Que tengan un historial médico y exploración física sin anomalías clínicamente relevantes en función del estudio y a criterio del investigador.
    E.4Principal exclusion criteria
    1. Patients with a history of allergy or hypersensitivity to the study medication, medication of rescue or any other non-steroidal anti-inflammatory drug (NSAID), opioids or acid acetylsalicylic, or any of its excipients.
    2. History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or edema
    angioneurotic.
    3. History of peptic ulcer, gastrointestinal disorders due to NSAID, gastrointestinal hemorrhage or other active hemorrhages.
    4. History of moderate to severe renal, hepatic or cardiac insufficiency.
    5. Hemorrhagic diathesis or other coagulation disorders.
    6. Epilepsy.
    7. Crohn's disease or ulcerative colitis.
    8. History of dependence on drugs of abuse or alcohol.
    9. History of any disease or disorder that, in the opinion of the investigator, could constitute a risk to the patient or modify the results of the study (eg patients with acute pain of any other origin or location at the time of surgery).
    10. Have had complications during the surgery, with duration greater than 1 hour and
    that required re-anesthesia (after the appropriate level of anesthesia has been reached).
    11. That they have consumed analgesics (including prescription and over-the-counter pain medications) during 48 hours prior to surgery, or in the previous 5 days in the case of consumption of inhibitors of the COX-2.
    12. Patients unable to abstain from alcohol, psychotropic drugs or sedatives (eg.
    benzodiazepines) or other medications that should not be administered due to the risk of interactions for 48 hours before the start of surgery and during the 12 hours following the administration of the study medication.
    13. That they have received an experimental drug or used an experimental medical device within the term of the 30 days prior to the selection.
    14. Pregnant or lactating women.
    15. That they can not comply with the requirements of the study or that in the opinion of the investigator should not take part.
    1. Pacientes con antecedentes de alergia o hipersensibilidad a la medicación del estudio, la medicación de rescate o a cualquier otro antiinflamatorio no esteroideo (AINE), a los opiáceos o al ácido acetilsalicílico, o a alguno de sus excipientes.
    2. Antecedentes de asma, broncoespasmo, rinitis aguda, pólipos nasales, urticaria o edema
    angioneurótico.
    3. Antecedentes de úlcera péptica, trastornos gastrointestinales por AINE, hemorragia gastrointestinal u
    otras hemorragias activas.
    4. Antecedentes de insuficiencia renal, hepática o cardiaca de moderada a grave.
    5. Diátesis hemorrágica u otros trastornos de la coagulación.
    6. Epilepsia.
    7. Enfermedad de Crohn o colitis ulcerosa.
    8. Antecedentes de dependencia de drogas de abuso o alcohol.
    9. Antecedentes de cualquier enfermedad o trastorno que, a criterio del investigador, pudiera constituir
    un riesgo para el paciente o alterar los resultados del estudio (p.ej. pacientes con dolor agudo de
    cualquier otro origen o localización en el momento de la cirugía).
    10. Que hayan tenido complicaciones durante la cirugía, con duración de la misma superior a 1 hora y
    que hayan requerido reanestesia (después de alcanzado el nivel de anestesia adecuado).
    11. Que hayan consumido analgésicos (incluyendo los de prescripción y los de venta sin receta) durante
    las 48 horas previas a la cirugía, o en los 5 días previos en el caso de consumo de inhibidores de la
    COX-2.
    12. Pacientes incapaces de abstenerse de consumir alcohol, psicofármacos o sedantes (p.ej.
    benzodiacepinas) u otros medicamentos que no deben administrarse debido al riesgo de interacciones
    durante 48 horas antes del inicio de la cirugía y durante las 12 horas siguientes a la administración de
    la medicación del estudio.
    13. Que hayan recibido un fármaco experimental o usado un dispositivo médico experimental en el plazo
    de los 30 días previos a la selección.
    14. Mujeres embarazadas o en período de lactancia.
    15. Que no puedan cumplir con los requisitos del estudio o que en opinión del investigador no deben
    participar.
    E.5 End points
    E.5.1Primary end point(s)
    intensity of pain, measured through a Scale Visual Analogic (VAS)
    intensidad del dolor, medida a través de una Escala Visual Analógica (EVA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 hours after the administration of the investigational medication
    6 horas tras administración del fármaco
    E.5.2Secondary end point(s)
    Difference in pain intensity (PIDt).
    Sum of the pain intensity differences (SPID).
    Pain relief (PRt) by the EVA scale score
    Relief of total pain (TOTPAR).
    Rate of responding patients.
    Rate of use of rescue medication.
    Time until the administration of rescue medication.
    Diferencia en intensidad de dolor (PIDt)
    Suma de las diferencias de intensidad de dolor (SPID)
    Alivio del dolor (PRt)
    Alivio del dolor total (TOTPAR).
    Tasa de pacientes respondedores.
    Tasa de uso de medicación de rescate.
    Tiempo hasta la administración de la medicación de rescate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Difference in pain intensity (PIDt) for each observation point established up to 7 hours (PIDt = PI0-PIt, where PI0 = intensity of pain in time t = 0 h according to the EVA and PIt = intensity of pain at each time point according to the EVA).
    Sum of the pain intensity differences (SPID). Up to 7 hours.
    Pain relief (PRt) from the start of the medication until 7 hours after the administration of the medication [by the EVA scale score (0: none of relief, 100: total relief)].
    Relief of total pain (TOTPAR) until 7 hour.
    Rate of responding patients: end of the study.
    Rate of use of rescue medication: end of the study.
    Time until the administration of rescue medication: end of the study.
    Diferencia en intensidad de dolor (PIDt) para cada punto de observación establecido hasta las 7 horas (PIDt= PI0-PIt, siendo PI0=intensidad de dolor en el tiempo t=0 h según la EVA y PIt= intensidad de dolor en cada punto de tiempo según la EVA).
    Suma de las diferencias de intensidad de dolor (SPID).hasta las 7 horas.
    Alivio del dolor (PRt) desde el inicio de la medicación hasta 7 horas después de la
    administración del medicamento [mediante la puntuación de la escala EVA (0: nada de
    alivio, 100:alivio total)].
    Alivio del dolor total (TOTPAR) hasta las 7 horas.
    Tasa de pacientes respondedores: al final del estudio.
    Tasa de uso de medicación de rescate: al final del estudio.
    Tiempo hasta la administración de la medicación de rescate: al final del estudio.
    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 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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned5
    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
    Ultimo paciente, ultima visita
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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: 112
    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 state112
    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 Decision2018-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA