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    Summary
    EudraCT Number:2014-001923-53
    Sponsor's Protocol Code Number:7980
    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:2015-07-10
    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 number2014-001923-53
    A.3Full title of the trial
    Intravenous iron, early functional recovery and delirium
    in patients atients with hip fracture
    Hierro intravenoso, recuperación funcional precoz y delirium en
    pacientes con fractura de cadera
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protocol treatment of anemia with iron in elderly patients undergoing hip fracture
    Protocolo de tratamiento con hierro de la anemia en los pacientes ancianos intervenidos de fractura de cadera
    A.4.1Sponsor's protocol code number7980
    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 SponsorRafael Bielza Galindo
    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 supportRafael Bielza Galindo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Medicina Interna/Geratria- Hospital Infanta Sofía
    B.5.2Functional name of contact pointRafael Bielza Galindo
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Europa, 34.
    B.5.3.2Town/ citySan Sebastián de los Reyes, Madrid
    B.5.3.3Post code28702
    B.5.3.4CountrySpain
    B.5.4Telephone number034911914000
    B.5.6E-mailrafael.bielza@salud.madrid.org
    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 HIERRO SACAROSA NORMON
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON 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 nameHIERRO SACAROSA NORMON
    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 INNIron Sucrose
    D.3.9.1CAS number 8047-67-4
    D.3.9.3Other descriptive nameIRON SUCROSE
    D.3.9.4EV Substance CodeSUB16439MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Salina Fisiologica Grifols
    D.2.1.1.2Name of the Marketing Authorisation holderGrifols
    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 nameSalina Fisiologica Grifols
    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 INNsodium chloride
    D.3.9.1CAS number 8028-77-1
    D.3.9.3Other descriptive nameSALINE
    D.3.9.4EV Substance CodeSUB20722
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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
    Hip fracture
    Fractura de cadera
    E.1.1.1Medical condition in easily understood language
    Hip fracture
    Fractura de cadera
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10020100
    E.1.2Term Hip fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the incidence of postoperative delirium and functional gain in terms of the change in the Barthel scale between admission and discharge in patients with hip fracture between treated and untreated patients with intravenous iron.
    Comparar la incidencia de delirium postoperatorio y la ganancia funcional, en términos del cambio en la escala Barthel entre ingreso y alta, en los pacientes con fractura de cadera entre los pacientes tratados y los no tratados con hierro intravenoso.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    • Evaluate the effectiveness of the administration of intravenous iron in patients with hip fracture to reduce transfusion requirements, both in the percentage of transfused, and the number of packed red blood cells needed.
    • To evaluate the safety of administration of iron sucrose
    intravenously.
    • Compare the number of bacterial infections (urinary, respiratory
    and surgical) wound between treated and untreated patients
    with intravenous iron.
    • Predict whether the treated patients have shorter length of stay
    hospital that treated.
    • Estimate whether treatment decreases mortality and readmissions within 30 days of the study patients.
    • Evaluar la eficacia de la administración de hierro intravenoso en los pacientes con fractura de cadera para reducir las necesidades transfusionales, tanto en el porcentaje de transfundidos, como en el número de concentrados de hematíes necesarios.
    • Evaluar la seguridad de la administración de hierro-sacarosa
    intravenoso.
    • Comparar el número de infecciones bacterianas (urinarias, respiratorias
    y de la herida quirúrgica) entre los pacientes tratados y los no tratados
    con hierro intravenoso.
    • Predecir si los pacientes tratados tienen menor tiempo de estancia
    hospitalaria que los tratados.
    • Estimar si el tratamiento disminuye la tasa de mortalidad y reingresos a los 30 días de los pacientes del estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients included in the study with hip fracture
    osteoporotic treated in our unit, with the following characteristics:
    • Age over 75 years
    • Having borrowed agreed to participate in the study by signing the
    corresponding Informed Consent Document.
     
    Se incluyen en el estudio aquellos pacientes con fractura de cadera
    osteoporótica atendidos en nuestra unidad, con las siguientes características:

    • Edad superior a 75 años

    • Haber prestado su conformidad a participar en el estudio mediante firma del correspondiente Documento de Consentimiento Informado.


    E.4Principal exclusion criteria
    Exclusion criteria:
    • Hypersensitivity to oral or parenteral preparations of iron.
    • Asthma or other severe atopy.
    • Withdrawal of informed consent.
    • No indication of surgical fracture
    Criterios de exclusión:
    • Hipersensibilidad a preparados de hiero parenteral u oral.
    • Asma u otras atopias severas.
    • Revocación del consentimiento informado.
    • No indicación quirúrgica de su fractura
    E.5 End points
    E.5.1Primary end point(s)
    Main efficacy endpoints:
    • The change in the Barthel scale between admission and discharge (functional gain):
    • Percentage of patients with "delirium" at some point of stay after surgery.

    Description of variables :
    • Functional Gain:
    - Barthel index at DISCHARGE - INCOME Barthel index at
    - A top 5 point difference is considered significant.

    • Delirium : presence of delirium from the patient to the ward from the recovery room arrives until he leaves hospital .
    1. Acute onset and fluctuating course
    Have you noticed an acute change in mental status of the patient?
    If the answer is No, not follow the questionnaire
    Two . Disturbance in attention
    Does the patient is easily distracted or have difficulty following
    a conversation?
    If the answer is No, not follow the questionnaire
    3. Disorganized thinking
    Does the patient expresses ideas or incoherent conversations or confuse people ?
    4. Altered level of consciousness
    Is altered level of consciousness of the patient ( vigilant , lethargic, stuporous ) ?

    For the diagnosis of delirium the first two criteria are necessary and at least one of the two last
    Variables principales de eficacia:
    • El cambio en la escala Barthel entre ingreso y alta (Ganancia funcional):
    • Porcentaje de pacientes que presentan “delirium” en algún momento de la estancia tras la cirugía.

    Descripción de las variables:
    • Ganancia funcional:
    - ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO
    - Una diferencia superior a 5 puntos, se considera significativa.

    • Delirium: presencia de delirium desde que llega el paciente a planta procedente de la sala de reanimación, hasta que se va de alta hospitalaria.
    1. Comienzo agudo y curso fluctuante
    ¿Ha observado un cambio agudo en el estado mental del paciente?
    Si la contestación es No, no seguir el cuestionario
    2. Alteración de la atención
    ¿El paciente se distrae con facilidad o tiene dificultad para seguir
    una conversación?
    Si la contestación es No, no seguir el cuestionario
    3. Pensamiento desorganizado
    ¿El paciente manifiesta ideas o conversaciones incoherentes
    o confunde a las personas?
    4. Alteración del nivel de conciencia
    ¿Está alterado el nivel de conciencia del paciente (vigilante, letárgico, estuporoso)?
    Para el diagnóstico de delirium son necesarios los dos primeros criterios y por lo menos uno de los dos últimos.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Description of variables:

    • Functional Gain:

    - Barthel index at DISCHARGE-ADMISSION Barthel index

    • Delirium: presence of delirium from the patient to the ward from the recovery room arrives until he leaves hospital discharge.
    Descripción de las variables:
    • Ganancia funcional:
    - ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO

    • Delirium: presencia de delirium desde que llega el paciente a planta procedente de la sala de reanimación, hasta que se va de alta hospitalaria.

    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Functional Efficiency defined as Barthel index at DISCHARGE-ADMISSION Barthel index at / LENGTH OF STAY postsurgical.

    • Change in functional scale (WALKING) Red Cross between admission and discharge.

    • Percentage of patients required transfusion (pre, intra, post) and number of concentrates at all times

    • Percentage of patients with bacterial infections (urinary, respiratory and surgical wound) during admission

    • Length of stay (preoperative and global)

    • Mortality during stay

    • Readmission within 30 days after discharge.

    Security Variables:

    • Blood transfusion

    • Side effects following administration of intravenous iron.

    Secondary efficacy endpoints :
    • Functional Efficiency defined as Barthel index at DSICHARGE-ADMISSION Barthel index at / LENGTH OF STAY postsurgical .

    • Change in functional scale ( WANDERING ) Red Cross between admission and discharge *

    • Percentage of patients required transfusion (pre , intra and postoperative ) and number of concentrates at all times

    • Percentage of patients with bacterial infections ( urinary, respiratory and surgical wound) during admission

    • Length of stay ( preoperative and global)

    • Mortality during stay

    • Readmission within 30 days after discharge.

    Security Variables :
    • Blood transfusion
    • Side effects following administration of intravenous iron .

    * Modified Barthel Index evaluates 11 items and each is scored as reflected in parentheses:
    1. Washing: ( 0 , 1, 3 , 4, 5 )
    2. Swimming: ( 0 , 1, 3 , 4, 5 )
    3. Eat (0, 2 , 5, 8 , 10)
    4. Using the toilet ( 0 , 2, 5 , 8, 10 )
    5. Climbing stairs (0, 2 , 5, 8 , 10)
    6. Dressing ( 0 , 2, 5 , 8, 10 )
    7. Control stool ( 0 , 2, 5 , 8, 10 )
    8. Urine Control ( 0 , 2, 5 , 8, 10 )
    9. Scroll ( 0 , 3, 8 , 12, 15 )
    10. Wheelchair ( 0 , 1, 3 , 4, 5 )
    11. Chair bed ( 0, 3 , 8, 12, 15 )
    Transfer (0, 3, 8, 12, 15)

    Functional Scale ** Red Cross :
    0 . Was totally worth by itself. Walking normally.
    1. Enough Performs the actions of everyday life. Wander with some difficulty. Total continence.
    2 . Having Difficulty in daily acts , so sometimes you need help . Wander using cane or similar. Rare full continence or incontinence.
    3 . Grave difficulty in many acts of daily life. Wander hard, helped at least one person . Occasional incontinence .
    4 . Need Help for almost every event . Wander helped with extreme difficulty ( 2 people). Habitual incontinence.
    5. Plant or couch at home . Total incontinence . You need continuous nursing care

    Adverse effects of iron *** :
    - Categorized NO / YES
    - Hypotension , fever, tremors , reactions at the injection site , nausea , rash and pruritus. Other (specify )
    Variables secundarias de eficacia:
    • Eficiencia funcional definida como: ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO/ESTANCIA POSTQUIRÚRGICA.

    • Cambio en la escala funcional (marcha) Cruz Roja entre ingreso y alta*

    • Porcentaje de pacientes de necesitan transfusión (pre, intra y postcirugía) y número de concentrados en cada momento

    • Porcentaje de pacientes que presentan infecciones bacterianas (urinarias, respiratorias y de la herida quirúrgica) durante el ingreso

    • Duración de la estancia (prequirúrgica y global)

    • Mortalidad durante la estancia

    • Reingreso durante los 30 días siguientes tras el alta.

    Variables de Seguridad:
    • Transfusión sanguínea
    • Efectos secundarios tras la administración del hierro intravenoso.

    *Indice de Barthel Modificado: evalúa 11 items y cada uno de ellos se puntúa como se refleja entre paréntesis:
    1. Aseo personal: (0 ,1, 3, 4, 5)
    2. Bañarse: (0 ,1, 3, 4, 5)
    3. Comer (0, 2, 5, 8, 10)
    4. Usar el retrete (0, 2, 5, 8, 10)
    5. Subir escaleras (0, 2, 5, 8, 10)
    6. Vestirse (0, 2, 5, 8, 10)
    7. Control de heces (0, 2, 5, 8, 10)
    8. Control de orina (0, 2, 5, 8, 10)
    9. Desplazarse (0, 3, 8, 12, 15)
    10. Silla de ruedas (0, 1, 3, 4, 5)
    11. Traslado silla- cama (0, 3, 8, 12, 15)

    ** Escala de Cruz Roja Funcional:
    0. Se vale totalmente por sí mismo. Anda con normalidad.
    1. Realiza suficientemente los actos de la vida diaria. Deambula con alguna dificultad. Continencia total.
    2. Tiene alguna dificultad en los actos diarios, por lo que, en ocasiones, necesita ayuda. Deambula con ayuda de bastón o similar. Continencia total o rara incontinencia.
    3. Grave dificultad en bastantes actos de la vida diaria. Deambula difícilmente, ayudado al menos por una persona. Incontinencia ocasional.
    4. Necesita ayuda para casi todos los actos. Deambula ayudado con extrema dificultad (2 personas). Incontinencia habitual.
    5. Inmovilizado en casa o sillón. Incontinencia total. Necesita cuidados continuos de enfermería

    ***Efectos adversos del hierro:
    - Categorizados NO / SI
    - Hipotensión, fiebre y temblores, reacciones en el punto de inyección, náuseas, erupción cutánea y prurito. Otras (especificar)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Functional Efficiency defined as Barthel index at ADMISSION-DISCHARGE Barthel index at / LENGTH OF STAY postsurgical.
    • Functional Scale (WALKING) Red Cross: measured at admission and at discharge.
    • Transfusion: Preoperative, intraoperative and postoperative.
    • Patients who have side effects to intravenous iron during admission.
    • Percentage of patients with bacterial infections (urinary, respiratory and surgical wound) during admission
    • Preoperative stay: days from admission to the day of surgery.
    • Global Stay: days from admission to discharge.
    • Mortality during hospital stay.
    • Readmission for medical or surgical cause during the 30 days after discharge.
    • Eficiencia funcional definida como: ÍNDICE DE BARTHEL AL ALTA-ÍNDICE DE BARTHEL AL INGRESO/ESTANCIA POSTQUIRÚRGICA.
    • Escala funcional (marcha) de Cruz Roja: medida al ingreso y al alta.
    • Transfusión: Preoperatoria, intraoperatoria y postoperatoria
    • Pacientes que presentan efectos secundarios a hierro intravenoso durante el ingreso.
    • Porcentaje de pacientes que presentan infecciones bacterianas (urinarias, respiratorias y de la herida quirúrgica) durante el ingreso
    • Estancia prequirúrgica: días desde el ingreso hasta el día de la cirugía.
    • Estancia Global: días desde el ingreso hasta el alta.
    • Mortalidad durante la estancia hospitalaria.
    • Reingreso por causa clínica o quirúrgica durante los 30 días siguientes tras el alta.
    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) 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) 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state200
    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 Decision2015-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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