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    Summary
    EudraCT Number:2012-000126-22
    Sponsor's Protocol Code Number:A18116378
    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:2012-05-29
    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 number2012-000126-22
    A.3Full title of the trial
    A Single Blind (Sponsor-unblinded), Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of GSK1070806 in the Treatment of Obese Subjects with T2DM.
    Estudio simple ciego (Promotor no ciego),controlado con placebo y de grupos paralelos para investigar la eficacia y la seguridad de GSK1070806 en el tratamiento de sujetos obesos con DMT2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of an antibody which targets the anti-IL18 cytokine in subjects with Type 2 Diabetes Mellitus.
    Estudio para evaluar la seguridad y la eficacia de un anticuerpo anti-citoquina IL18 en pacientes con Diabetes Mellitus Tipo II.
    A.4.1Sponsor's protocol code numberA18116378
    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 SponsorGlaxoSmithKline, 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 supportGSK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1B
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402089904466
    B.5.5Fax number+4402089901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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.3.2Product code GSK1070806
    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.3.9.2Current sponsor codeGSK1070806
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboInfusion
    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
    Type 2 Diabetes Mellitus
    Diabetes mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus
    Diabetes mellitus tipo 2
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    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
    To evaluate the efficacy of two repeat intravenous dose administrations of GSK1070806 in subjects with T2DM.
    Evaluar la eficacia de dos dosis repetidas de GSK1070806 administradas por vía i.v. en sujetos con DMT2.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of two repeat intravenous dose administrations of GSK1070806 in obese subjects with T2DM.
    - To evaluate the effect of two repeat intravenous dose administrations of GSK1070806 on additional markers of efficacy, in obese subjects with T2DM.
    - To evaluate the plasma PK of repeat intravenous doses of GSK1070806 in obese subjects with T2DM.
    - To investigate the effect of repeat intravenous doses of GSK1070806 on free and drug bound IL 18 levels (if measurable) in obese subjects with T2DM.
    - To explore the pharmacodynamic (PD) effect of repeat intravenous doses of GSK1070806 on biomarkers of inflammation and metabolic disease.
    - To investigate the effect of repeat intravenous doses of GSK1070806 on body composition in obese subjects with T2DM.
    - To assess the potential of anti-GSK1070806 antibody formation following repeat intravenous administration of GSK1070806.
    ? Evaluar la seguridad y tolerabilidad de dos dosis repetidas de GSK1070806 administradas por vía i.v. en sujetos obesos con DMT2.
    ? Evaluar el efecto de dos dosis repetidas de GSK1070806 administradas por vía i.v. en marcadores adicionales de eficacia, en sujetos obesos con DMT2.
    ? Evaluar la FC en plasma de las dosis i.v. repetidas de GSK1070806 en sujetos obesos con DMT2.
    ? Investigar el efecto de las dosis i.v. Repetidas de GSK1070806 en los niveles de IL-18 TANTO unida al fármaco y como libre (si son medibles) en sujetos obesos con DMT2.
    ? Examinar el efecto farmacodinámico (FD) de las dosis i.v. Repetidas de GSK1070806 en los biomarcadores inflamatorios y en la enfermedad metabólica.
    ? Investigar el efecto de dosis i.v. Repetidas de GSK1070806 en la composición del organismo en sujetos obesos con DMT2.
    ? Evaluar el potencial de la formación del anticuerpo anti-GSK1070806 tras la administración i.v. de dosis repetidas de GSK1070806.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply.
    1. A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. Subjects may be entered if they have stable hypertension or dyslipidemia on therapy, provided there is no change in either the type or dose of medications during the 3-month period before the study. Subjects with other conditions except as noted in the Exclusion criteria may be included only if the investigator and GSK medical monitor agree that the condition is unlikely to introduce additional risk factors and will not interfere with study procedures.
    2. Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent.
    3. HbA1c levels >= 7.0 % and <= 9.5%; at Screening.
    4. On a stable dose of monotherapy with metformin for three months prior to screening, and at a total daily dose greater than or equal to 1000 mg for at least 2 months prior to dosing.
    5. Fasting plasma glucose level < 13.3 mmol/L (240 mg/dL) at screening.
    6. Obese with BMI >= 30 kg/m2, and < 40 kg/m2.
    7. Presence of microalbuminuria: 30-300mg/L albumin in urine or Albumin Creatinine Ratio (ACR) >= 3.5 mg/mmol (female) or >=2.5 mg/mmol (male) and <= 30 mg/mmol (female and male).
    8. The subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    9. A female subject is eligible to participate if she is of:
    - Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the full protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
    - Child-bearing potential (only applicable for sites where regulation allows for their inclusion) and agrees to use one of the contraception methods listed in Section 7.1. of the study Protocol, Acceptable contraception is required by WCBP for one month prior to screening, during the course of the study and 210 days after the first dose of study drug.
    10. Male subjects must agree to use one of the contraception methods listed in Section 7.1.2 of the study Protocol. This criterion must be followed from the time of the first dose of study medication until after the last follow-up visit at Day 210.
    11. ALT < 2xULN; alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    12. Single or Average QTc, QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
    Se considerará que un sujeto es elegible para la inclusión en este estudio solo si aplican todos los siguientes criterios.
    1. Diagnóstico de DMT2 determinado por un médico y en base a una evaluación médica que incluya historia clínica, exploración física y pruebas analíticas, y que aparezca al menos 6 meses antes del screening/selección. Los sujetos pueden participar si presentan hipertensión estable o dislipidemia en tratamiento, siempre que no haya cambios ni en el tipo ni en la dosis de fármacos durante el periodo de 3 meses antes del estudio. Los sujetos con enfermedades distintas de las señaladas en los criterios de exclusión, pueden ser incluidos solo si el Investigador y el Monitor Médico de GSK acuerdan que es poco probable que la enfermedad suponga factores de riesgo adicionales y que ésta no interfiera con los procedimientos del estudio.
    2. Hombres y mujeres de entre 18 y 70 años de edad inclusive, en el momento de la firma del consentimiento informado.
    3. Niveles de HbA1c >= 7,0% y <= 9,5% en el screening/selección.
    4. En tratamiento estable de metformina en monoterapia durante tres meses antes del screening/selección y una dosis diaria total superior o igual a 1000 mg durante al menos 2 meses antes de la administración de la dosis.
    5. Nivel de glucosa en el plasma en ayunas < 240 mg/dl (13,3 mmol/l) en el screening/selección.
    6. Sujetos obesos con IMC >= 30 kg/m2 y < 40 kg/m2.
    7. Presencia de microalbuminuria: 30-300 mg/l de albúmina en orina o proporción de albumina a creatinina (ACR) >= 3,5 mg/mmol (mujeres) o >= 2,5 mg/mmol (hombres) y <= 30 mg/mmol (mujeres y hombres).
    8. El sujeto puede dar su consentimiento informado por escrito, esto implica un cumplimiento de los requerimientos y restricciones detalladas en el consentimiento informado .
    9. Una mujer será elegible para participar si:
    ? Se trata de una mujer infértil, lo cual se define como mujeres premenopáusicas con ligadura de trompas o histerectomía; o posmenopáusicas, lo cual se define como 12 meses de amenorrea espontánea [en casos dudosos, una muestra de sangre junto con la hormona estimulante de folículos (FSH) > 40 MUI/ml y estradiol < 40 pg/ml (< 140 pmol/l) es confirmatorio]. Las mujeres en terapia hormonal sustitutiva (THS) y cuyo estado menopáusico sea dudoso, deberán usar uno de los métodos anticonceptivos en el protocolo completo si desean continuar con su THS durante el estudio. De lo contrario, deben suspender la THS para permitir la confirmación de un estado posmenopáusico antes de la inclusión en el estudio. Para la mayoría de las formas de THS, transcurrirán al menos de 2 a 4 semanas entre la suspensión de la terapia y la extracción de sangre; este intervalo depende del tipo y la posología de la THS. Tras la confirmación de su estado posmenopáusico, pueden reanudar el uso de la THS durante el estudio sin usar métodos anticonceptivos.
    ? Se trata de MEF (solamente aplicable para los centros donde la legislación permita su inclusión) y acuerden usar uno de los métodos anticonceptivos enumerados en la Sección 7.1. Se requiere el uso de anticonceptivos aceptables por las MEF durante un mes antes del screening/selección, durante el curso del estudio y 210 días después de la primera dosis del fármaco del estudio.
    10. Los sujetos varones deben acordar el uso de uno de los métodos anticonceptivos enumerados en la Sección 7.1.2. Se debe seguir este criterio desde el momento de la primera dosis del fármaco del estudio hasta después de la última visita de seguimiento en el Día 210.
    11. ALT < 2 x LSN; fosfatasa alcalina y bilirrubina <= 1,5 x LSN (la bilirrubina aislada > 1,5 x LSN es aceptable si la bilirrubina se fracciona y bilirrubina directa < 35%).
    12. Valor único o medio de los intervalos QTc, QTcB o QTcF < 450 ms; o QTc < 480 ms en sujetos con bloqueo de rama.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Current evidence, or history within the last 7 days, of an influenza-like illness as defined by fever (>38°C) and two or more of the following symptoms: cough, sore throat, runny nose, sneezing, limb / joint pain, headache, vomiting / diarrhoea in the absence of a known cause, other than influenza.
    2. Use of anti-inflammatory drugs including corticosteroids, chronic maintenance therapy with NSAIDs, anti-Tumor Necrosis Factor (anti-TNF) or anti-Interleukin-1 (anti-IL1) within 60 days prior to dosing. NSAIDs are permitted for intermittent use during the course of the study.
    3. Current evidence of ongoing or acute infection, history of repeated, chronic or opportunistic infections (e.g. recurrent folliculitis, other cutaneous infections or repeated pneumonia) or history of a serious bacterial infection within 6 months of randomisation.
    4. History of malignancy or significant cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions that in the opinion of the investigator and/or GSK Medical Monitor, places the subject at an unacceptable risk as participant in this trial.
    5. History chronic granulomatous infections, such as of Mycobacterium tuberculosis or any other previous Mycobacterium infection.
    6. Creatinine clearance less than 60ml/min
    7. Screens positive of Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV)
    8. History of a severe allergic reaction, anaphylaxis or immunodeficiency.
    9. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    10. A positive pre-study drug/alcohol screen.
    11. History of regular alcohol consumption within 6 months of the study defined as:
    An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
    12. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
    13. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    14. Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John?s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
    15. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    16. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    17. Pregnant females as determined by positive serum or urine hCG test at screening.
    18. Lactating females.
    19. Unwillingness or inability to follow the procedures outlined in the protocol.
    20. Subject is mentally or legally incapacitated.
    21. Subject has received a live attenuatedvaccine(s) within 30 days of randomisation or will require vaccination with a live attenuated vaccine prior to the end of the study.
    Se considerará que un sujeto no es elegible para su inclusión en este estudio si aplica cualquiera de los siguientes criterios:
    1. Indicios actuales o antecedentes en los últimos 7 días de síntomas pseudogripales, lo cual se define como fiebre (> 38° C) y dos o más de los siguientes síntomas: tos, dolor de garganta, rinorrea, estornudos, dolor en las extremidades/ articulaciones, cefalea, vómitos/ diarrea en ausencia de una causa conocida, distinta de la gripe.
    2. Uso de antiinflamatorios como corticoesteroides, tratamiento de mantenimiento crónico con AINE, anti-factor de necrosis tumoral (anti-FNT) o anti-interleucina 1 (anti-IL1) en los 60 días antes de la administración de la dosis. Se permite el uso intermitente de AINE durante el curso del estudio.
    3. Indicios actuales de infección en curso o aguda, antecedentes de infecciones oportunistas o crónicas repetidas (p. ej., foliculitis recurrente, otras infecciones cutáneas o neumonía repetida) o antecedentes de una infección bacteriana en el plazo de 6 meses de la aleatorización.
    4. Antecedentes de neoplasia maligna o enfermedades cardiacas, pulmonares, metabólicas, renales, hepáticas o gastrointestinales significativas que, a juicio del Investigador y/ o el Monitor Médico de GSK, expongan al sujeto a un riesgo inaceptable como participante en este ensayo.
    5. Antecedentes de infecciones granulomatosas crónicas, tales como tuberculosis por Mycobacterium o cualquier otra infección previa por dicha bacteria.
    6. Aclaramiento de creatinina menor de 60 ml/min.
    7. Resultado positivo en la prueba para el antígeno de superficie de hepatitis B, el anticuerpo de hepatitis C o el virus de la inmunodeficiencia humana (VIH).
    8. Antecedentes de reacciones alérgicas graves, anafilaxia o inmunodeficiencia.
    9. Antecedentes de enfermedad hepática crónica o curso actual de la misma, o anomalías biliares o hepáticas conocidas (con excepción del síndrome de Gilbert o presencia asintomática de cálculos biliares).
    10. Un resultado positivo en la prueba para drogas/ alcohol antes del inicio del estudio.
    11. Antecedentes de alcoholismo habitual dentro de 6 meses del estudio definido como:
    Una ingesta media semanal > 21 unidades para hombres o > 14 unidades para mujeres. Una unidad equivale a 8 g de alcohol: media jarra (~240 ml) de cerveza, 1 copa (125 ml) de vino o 1 pequeña cantidad (25 ml) de otra bebida alcohólica.
    12. El sujeto haya participado en un ensayo clínico y haya recibido un producto en fase de investigación dentro del siguiente periodo de tiempo antes del primer Día de administración en el estudio actual: 30 días, 5 semividas o dos veces la duración del efecto biológico del producto en fase de investigación (lo que sea más largo).
    13. Exposición a más de cuatro entidades químicas nuevas dentro de los 12 meses antes del primer Día de la administración.
    14. No poder abstenerse del uso de fármacos prescritos o no prescritos, incluyendo complejos vitamínicos, suplementos nutricionales y herbales (como hierba de San Juan) dentro de los 7 días (o 14 días si el fármaco es un inductor de enzimas potencial) o 5 semividas (lo que sea más largo) antes de la primera dosis del fármaco del estudio, a menos que, a juicio del Investigador y el Monitor Médico de GSK, no interfieran con los procedimientos del estudio o comprometan la seguridad del sujeto.
    15. Antecedentes de sensibilidad a cualquiera de los fármacos del estudio, o componentes de los mismos o antecedentes de alergias al fármaco u otras alergias que, a juicio del Investigador o el Monitor Médico de GSK, contraindiquen su participación.
    16. En casos en los que la participación en el estudio tendría como consecuencia la donación de sangre o productos hemoderivados superior a 500 ml dentro de un periodo de 56 días.
    17. Mujeres embarazadas según lo determinado por pruebas positivas de hCG en orina y suero en el screening/selección.
    18. Mujeres en periodo de lactancia.
    19. Falta de voluntad o de capacidad para seguir los procedimientos descritos en el protocolo.
    20. Sujetos mental o legalmente incapacitados.
    21. Sujetos que hayan recibido vacunas vivas atenuadas dentro de los 30 días previos de la aleatorización o que requieran la administración de una vacuna viva atenuada antes del final del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in fasting plasma glucose and weighted mean glucose AUC (0-4hrs) post-Mixed Meal Test (MMT)
    Cambio desde el valor basal en la glucosa en plasma en ayunas y la ABC de la glucosa media ponderada (0-4 horas) tras la prueba de comida mixta (PCM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 29, 57 and 85.
    Días 29, 57 y 85.
    E.5.2Secondary end point(s)
    ? Safety and tolerability parameters include: adverse events , clinical laboratory tests, electrocardiograms (ECGs), and vital signs.
    ? Change from baseline in % HbA1c, fasting blood insulin, and C-peptide levels
    ? Change from baseline in weighted mean insulin and C-peptide levels [AUC (0-4hrs)] post-MMTand derived measures of insulin sensitivity and ?-cell function.
    - Los parámetros de seguridad y tolerabilidad incluyen: acontecimientos adversos, pruebas clínicas de laboratorio, electrocardiogramas (ECG) y constantes vitales.
    - Cambio desde el valor basal en el porcentaje (%) de HbA1c, insulina en plasma en ayunas, glucagón y niveles del péptido C.

    - Cambio desde el valor basal en la insulina media ponderada, glucagón y niveles del péptido C [ABC (0-4 horas)] tras la PCM y determinaciones derivadas de la sensibilidad a la insulina y la función de las células? .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 29, 57 and 85.
    Días 29, 57 y 85.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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 trial3
    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 concerned3
    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 end of the study is defined as the last subject?s last visit.
    Última visita, último sujeto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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)
    Subjects will not receive any additional treatment from GSK after completion of the study because the indication being studied is not life threatening or seriously debilitating and/or other treatment options are available.
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient?s medical condition, whether or not GSK is providing specific post-study treatment.
    Los sujetos no recibirán ningún tratamiento adicional de GSK después de la finalización del estudio, ya que la indicación que se estudia no es potencialmente mortal o gravemente debilitante y/ o hay disponibles otras opciones de tratamiento.
    El Investigador es responsable de garantizar que se ha prestado atención a los cuidados posteriores al estudio del estado médico del paciente, esté GSK proporcionando tratamiento específico posterior al tratamiento o 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 Decision2012-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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