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    Summary
    EudraCT Number:2012-001858-25
    Sponsor's Protocol Code Number:MEIN/11/FEB-GOU/001
    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:2013-01-22
    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 number2012-001858-25
    A.3Full title of the trial
    A multicentre, randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout.
    Estudio multicéntrico, aleatorizado, doble ciego y en grupos paralelos, para evaluar la eficacia terapéutica y la seguridad del FEBUXOSTAT (suministrado una vez al día) y la eficacia terapéutica y la seguridad del ALOPURINOL en la concentración de urato sérico en sujetos con hiperuricemia y gota.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study on the therapeutic efficacy and safety of Febuxostat and Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout
    Un estudio clínico sobre la eficacia terapéutica y la seguridad de febuxostat y alopurinol sobre la concentración de ácido úrico en suero en sujetos que padecen hiperuricemia y la gota
    A.3.2Name or abbreviated title of the trial where available
    Double-blind, randomised, multicenter, phase IV study in hyperuricemic gout subjects
    Doble ciego, aleatorizado, multicéntrico, de fase IV en pacientes de gota hiperuricémicos
    A.4.1Sponsor's protocol code numberMEIN/11/FEB-GOU/001
    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 SponsorMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
    B.1.3.4CountryLuxembourg
    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 supportMENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnopharma Srl
    B.5.2Functional name of contact pointElisa Dall'O'
    B.5.3 Address:
    B.5.3.1Street Addressvia Lavoratori Autobianchi 1
    B.5.3.2Town/ cityDesio (MB)
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number00390362573128
    B.5.5Fax number00390362544211
    B.5.6E-maile.dallo@innopharma.it
    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 ADENURIC
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxemburg 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.3.1Product nameFebuxostat
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFEBUXOSTAT
    D.3.9.1CAS number 144060-53-7
    D.3.9.4EV Substance CodeSUB25382
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 ADENURIC
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxemburg 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.3.1Product nameFebuxostat
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFEBUXOSTAT
    D.3.9.1CAS number 144060-53-7
    D.3.9.4EV Substance CodeSUB25382
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 ZYLORIC
    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.3.1Product nameAllopurinol
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 Colchicina Lirca
    D.2.1.1.2Name of the Marketing Authorisation holderACARPIA Serviços Farmaceuticos LDA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameColchicine LIRCA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNColchicine
    D.3.9.1CAS number 64-86-8
    D.3.9.2Current sponsor codeColchicine
    D.3.9.3Other descriptive nameCOLCHICINE
    D.3.9.4EV Substance CodeSUB01420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0 to 3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hyperuricemia and gout
    hiperuricemia y gota
    E.1.1.1Medical condition in easily understood language
    Gout is caused by elevated levels of uric acid in the blood which crystallize, and the crystals are deposited in joints, tendons, and surrounding tissues.
    La gota es causada por niveles elevados de ácido úrico en la sangre que cristalizan, y los cristales se depositan en las articulaciones, tendones y tejidos circundantes.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10018627
    E.1.2Term Gout
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10020907
    E.1.2Term Hyperuricemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary study objective is to determine whether Febuxostat 80 mg, given once a day, is better than Allopurinol 300 mg/die considering the proportion of subjects, at visit 1 (week 4), whose serum urate concentrations will be below 6 mg/dL (357 µmol/L).
    El objetivo primario del estudio consiste en determinar si el febuxostat 80 mg, administrado una vez al día, es mejor que el alopurinol 300 mg/día, considerando la proporción de sujetos que, en la consulta 1 (es decir, después de cuatro semanas de tratamiento), tienen una concentración de urato sérico inferior a 6 mg/dl (357 µmol/l).
    E.2.2Secondary objectives of the trial
    Secondary objectives are the evaluation of the efficacy of Febuxostat 80 mg, given after a four-week treatment with Allopurinol 300 mg in lowering serum urate concentration below 6 mg/dL at visit 2 (week 8 after randomisation).
    The evaluation of efficacy of Febuxostat 120 mg, given once a day, after four weeks treatment with Febuxostat 80 mg, versus Febuxostat 80 mg and Allopurinol 300 mg/die considering the proportion of subjects at visit 2 (week 8) whose serum urate concentrations will be below 6 mg/dL (357 µmol/L) and considering the proportion of subjects at visit 6 (week 24), whose last 3 monthly (at week 16, 20 and 24) serum urate concentrations will be below 6 mg/dL (357 µmol/L).
    The comparison of efficacy of Febuxostat 80 and 120 mg, given once a day versus Allopurinol 300 mg/die by assessment of serum urate concentrations at each post baseline visits (visit 1, 2, 3, 4, 5 and 6).
    Evaluation of the effect of urate lowering therapy to gout flare incidence during the study.
    Evaluación de la eficacia del feb. 80mg, administrado después de 4 sem. de trat. con alop.300mg, en la reducción de urato serico por debajo de 6mg/dl en la consulta2 (ocho semanas después de la aleatorización). Evaluación de la eficacia del feb.120mg adm. una vez al día, después de 4 sem. de trat. con feb.80mg, con respecto al feb. 80 mg y al alop.300mg/día, considerando el porcentaje de sujetos con urato serico inferior a 6mg/dl (357µmol/l) en la consulta 2 (después de 8 semanas de tratamiento) y considerando, en la consulta 6, la proporción de sujetos que en los últimos 3 meses (respectivamente, en las sem.16,20y24) tenían urato serico inferior a 6mg/dl (357µmol/l). Comparación de la eficacia del feb 80y120mg, adm. una vez al día, con respecto al alop.300mg/día, desde la evaluación de la concentración de urato sérico en cada consulta (consultas1 2,3, 4,5y6). Evaluación del efecto de la terapia para la reducción del urato en la incidencia de los ataques agudos gotosos en el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects of both sexes suffering from hyperuricemia who had at least one episode of gout flare in their medical history
    Sign and symptoms of gout flare have to be resolved at least 48 hours before enrolment or randomisation
    Male or female subjects aged ?18 years
    Subjects willing and able to give written informed consent
    Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
    Serum uric acid ? 8.0 milligrams per decilitre (mg/dL) at baseline
    Subject willing to comply with the prophylaxis treatment
    Sujetos de ambos sexos con hiperuricemia, que han sufrido al menos un episodio agudo de gota en su historia clínica.
    Los signos y síntomas del ataque agudo de gota deben ser resueltos al menos 48 horas antes del control o de la aleatorización.
    Varones o mujeres de 18 años o más.
    Sujetos dispuestos y capaces de dar su consentimiento informado por escrito.
    Conformidad con los criterios preliminares de la Asociación Americana de Reumatología para la clasificación de la artritis aguda de gota primaria.
    Niveles séricos de ácido úrico ? 8,0 miligramos por decilitro (mg/dl), a la concentración basal.
    Sujetos dispuestos a recibir el tratamiento profiláctico.
    E.4Principal exclusion criteria
    Serum creatinine >1.5 mg/dL or calculated creatinine clearance < 60 milliliters per minutes (mL/min)
    Pregnancy or lactation
    Clinical evidence on screening visit of Ischaemic Heart Disease and/or Congestive Heart Failure
    Concurrent therapy with Losartan
    Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, theophylline or medications containing aspirin (>325 mg/day) or other salicylates
    Concurrent therapy with colchicine, naproxene, indomethacin if not used for gout flares prophylaxis
    Body Mass Index (BMI) >50 kilogram per square meter (kg/m²)
    A history or presence of xanthinuria, active liver disease or hepatic dysfunction judged clinically relevant in the opinion of the Investigator
    Other concurrent severe diseases (cancer, AIDS, thyroid disease etc.) judged clinically relevant in the opinion of the Investigator
    Subjects with AST and ALT and total bilirubin more than 1.5 x Upper Normal Limit
    Positive history for organ transplantation
    Dementia, psychosis, alcoholism (> 350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances
    Introduction of concurrent therapies among those not permitted and which cannot be suspended without harm to the subject
    Hypersensitivity or contraindications to use of the product under study
    Participation in other pharmacological clinical trials in the previous 4 months
    Conditions which in the Investigator?s opinion may interfere with the study?s execution or due to which the subject should not participate for safety reasons
    Risk of low subject cooperation
    Females of childbearing potential not using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner
    Lactose intolerance
    Creatinina sérica > 1,5 mg/dl o aclaramiento de la creatinina calculada < 60 mililitros por minuto (ml/min).
    Embarazo o lactancia.
    Evidencia clínica de cardiopatía isquémica o insuficiencia cardiaca congestiva en la consulta de control.
    Terapia concomitante con losartán.
    Terapia concomitante con agentes que reducen los niveles de urato, azatioprina, 6-mercaptopurina, diuréticos tiazídicos, teofilinas o fármacos que contienen aspirina (> 325 mg/día) u otros salicilatos.
    Terapia concomitante con colchicina, naproxeno o indometacina, si no se utilizan para la profilaxis de los ataques agudos de gota.
    Índice de masa corporal (BMI) > 50 kg por metro cuadrado (kg/m²).
    Historia o presencia de xantinuria, enfermedad hepática activa o disfunción hepática clínicamente relevantes a juicio del experimentador.
    Otras patologías concomitantes graves (cáncer, SIDA, enfermedades de la glándula tiroides etc.) consideradas clínicamente relevantes por el experimentador.
    Sujetos con AST y ALT y bilirrubina total más de 1,5 veces superior al límite superior normal.
    Trasplante previo de órganos.
    Demencia, psicosis, alcoholismo (> 350 g de etanol/semana) o abuso crónico de fármacos, estupefacientes o sustancias psicoactivas.
    Introducción de terapias concomitantes entre las no permitidas y que no pueden ser suspendidas sin causar daños al sujeto.
    Hipersensibilidad o contraindicaciones para el uso de los productos estudiados.
    Participación en otros estudios clínicos farmacológicos en los cuatro meses anteriores.
    Condiciones que, a juicio del experimentador podrían interferir con la realización del estudio o por las cuales el sujeto no debería participar por motivos de seguridad.
    Riesgo de escasa colaboración por parte del sujeto.
    Mujeres en edad fértil que no utilizan adecuadas precauciones anticonceptivas (implantes, inyectables, anticonceptivos orales combinados, dispositivos intrauterinos, abstinencia sexual o vasectomía de la pareja).
    Intolerancia a la lactosa.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects with serum urate levels < 6.0 mg/dL after 4 weeks of treatment (visit 1).
    Porcentaje de sujetos con niveles séricos de urato < 6,0 mg/dl después de cuatro semanas de tratamiento (consulta 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    visit 1
    consulta 1
    E.5.2Secondary end point(s)
    Percentage of subjects, in each treatment group, as defined at visit 1, with the serum urate levels <6.0 mg/dL after 8 weeks of treatment (visit 2).

    Percentage of subjects, in each treatment group, as defined at visit 2, with the last 3 serum urate levels (at 16, 20 and 24 weeks from the treatment start) < 6.0 mg/dL after 24 weeks of treatment (end of study) overall and within each of the three subgroups of subjects defined by baseline urate concentration (less than 9.0 mg/dL, at least 9.0 mg/dL but less than 10 mg/dL, 10 mg/dL or more).

    Percentage of subjects with serum urate levels <6.0 mg/dL at each study visit (after 12, 16, 20, 24 weeks of treatment).
    Mean values and percent reduction from baseline in serum urate levels, at each visit.

    Percentage of subjects with gout flares during the 24 weeks of treatment.
    Porcentaje de sujetos, en cada grupo de tratamiento definido en la consulta 1, con niveles séricos de urato < 6,0 mg/dl después de ocho semanas de tratamiento (consulta 2).

    Porcentaje de sujetos, en cada grupo de tratamiento definido en la consulta 2, con los últimos tres niveles séricos de urato (a 16, 20 y 24 semanas del inicio del tratamiento) < 6,0 mg/dl después de veinticuatro semanas de tratamiento (final del estudio), globales y divididos en los tres subgrupos definidos por la concentración basal de urato (inferior a 9,0 mg/dl, entre 9,0 y menos de 10 mg/dl, 10 mg/dl o más).

    Porcentaje de sujetos con niveles séricos de urato < 6,0 mg/dl en cada consulta de estudio (después de 12, 16, 20 y 24 semanas de tratamiento).

    Los valores medios y la reducción porcentual con respecto a la concentración basal de los niveles séricos de urato, en cada consulta.

    Porcentaje de sujetos con ataques agudos de gota durante las veinticuatro semanas de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above E.5.2
    véase E.5.2
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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 months8
    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 months8
    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: 224
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 224
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 448
    F.4.2.2In the whole clinical trial 448
    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
    nada
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
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