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    Summary
    EudraCT Number:2006-002033-21
    Sponsor's Protocol Code Number:NKV102551
    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:2006-07-18
    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 number2006-002033-21
    A.3Full title of the trial
    Estudio Fase III, multicéntrico, aleatorizado, doble ciego, con control activo, de grupos paralelos, para investigar la eficacia y seguridad de las formulaciones intravenosa y oral del antagonista de receptores de neuroquinina-1, casopitant, administradas en combinación con ZOFRAN y dexametasona, para la prevención de náuseas y vómitos inducidos por la quimioterapia en pacientes con neoplasias que van a recibir quimioterapia altamente emetógena con cisplatino.
    A.4.1Sponsor's protocol code numberNKV102551
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGW679769 Powder for Injection 90mg/vial
    D.3.2Product code GW679769
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 414910-30-8
    D.3.9.2Current sponsor codeGW679769
    D.3.9.3Other descriptive nameCasopitant
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 nameGW679769 Tablets 50mg
    D.3.2Product code GW679769
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 414910-30-8
    D.3.9.2Current sponsor codeGW679769
    D.3.9.3Other descriptive nameCasopitant
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 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 nameGW679769 Tablets 150mg
    D.3.2Product code GW679769
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 414910-30-8
    D.3.9.2Current sponsor codeGW679769
    D.3.9.3Other descriptive nameCasopitant
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Zofran Injection Premixed
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameZofran Injection Premixed
    D.3.2Product code Zofran
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOndansetron
    D.3.9.1CAS number 116002-70-1
    D.3.9.3Other descriptive nameZofran
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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: 5
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderGalen
    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 nameDexamethasone
    D.3.2Product code Dexamethasone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDexamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboPowder for infusion*
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Náuseas y vómitos inducidos por quimioterapia de poder emetogeno elevado.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo primario de este estudio es demostrar la superioridad de la terapia triple con casopitant, ZOFRAN y dexametasona, sobre la terapia doble con ZOFRAN y dexametasona, para la prevención de la emesis durante las 120 horas siguientes al inicio del primer ciclo de quimioterapia con cisplatino altamente emetógena (QAE).
    E.2.2Secondary objectives of the trial
    Determinar si la adición de casopitant mejora
    la prevención de la emesis en las fases aguda (0-24 h) y tardía (24-120 h) tras el primer ciclo de QAE.
    la prevención de la emesis en las fases aguda (0-24 h), tardía (24-120 h) y global (0-120 h) tras los ciclos subsiguientes de QAE.
    el control de las náuseas durante las 120 primeras horas y en las fases aguda y tardía después de cada ciclo de QAE.
    Cuantificar el impacto de los regímenes antieméticos sobre las actividades cotidianas, evaluado con el cuestionario Functional Living Index-Emesis (FLIE) tras el primer ciclo de QAE.
    Evaluar la satisfacción del sujeto con el régimen antiemético profiláctico y su disposición a utilizar el mismo régimen en futuros tratamiento quimioterápicos.
    Determinar la seguridad y la tolerabilidad de casopitant cuando se administra como parte del régimen antiemético descrito en este protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sujetos que comprendan la naturaleza y el objetivo de este estudio y los procedimientos del estudio y hayan dado su consentimiento informado por escrito confirmandolo.
    2. Hombres o mujeres de al menos 18 años de edad.
    3. Sujetos con diagnóstico de tumor sólido maligno que tengan previsto recibir su primer ciclo de quimioterapia citotóxica con cisplatino administrada como una dosis intravenosa única de 70mg/m2 durante 1-4 horas el Día 1, solo o en combinación con otros quimioterápicos. En los regímenes de combinación, los fármacos distintos de cisplatino de bajo-alto potencial emético deben administrarse después del cisplatino y completarse no más de 6 horas después del inicio de la infusión de cisplatino. Los taxanos sólo pueden administrarse el Día 1 del estudio.
    4. Estado funcional ECOG de 0, 1 ó 2.
    5. Sujetos con un estado hematológico y metabólico adecuado para recibir un régimen de cisplatino altamente emetógeno y que cumplan los siguientes criterios:
    - Neutrófilos totales 1500/mm3 (unidades estándar: 1,5 x 109/l)
    - Plaquetas 100.000/mm3 (unidades estándar: 100 x 109/l)
    - Bilirrubina 1,5 x LSN
    - Creatinina sérica 1,5mg/dl (unidades estándar: 132,6mol/l)
    O
    - Aclaramiento de creatinina 60ml/min
    - Los valores de las enzimas hepáticas deben estar por debajo de los siguientes límites
    Sin metástasis hepáticas conocidas: aspartato aminotransferasa (AST) y/o alanina aminotransferasa (ALT) 2,5 x límite superior normal
    Con metástasis hepática conocidas: AST y/o ALT 5,0 x límite superior normal
    6. Sujetos dispuestos y capaces de completar el diario del sujeto en cada ciclo del estudio.
    7. Las mujeres potencialmente fértiles deben estar de acuerdo en utilizar correctamente un método anticonceptivo aceptable; los métodos anticonceptivos aceptables para GSK, cuando se utilicen siempre y de acuerdo con las instrucciones del médico y del prospecto.
    E.4Principal exclusion criteria
    1. Ha recibido anteriormente quimioterapia citotóxica. Los tratamientos hormonales o biológicos previos están permitidos.
    2. Tiene previsto recibir tratamiento con cisplatino más de un día durante un único ciclo de terapia.
    3. Mujeres embarazadas o en período de lactancia.
    4. Ha presentado vómitos o náuseas significativas (ejemplo, 25mm en una EAV) tras la administración de quimioterapia de bajo potencial emetógeno en los 6 días anteriores a la infusión de cisplatino.
    5. Ha recibido radioterapia en tórax, abdomen o pelvis en los 10 días anteriores a la administración de la primera dosis de medicación del estudio y/o recibirá radioterapia en abdomen o pelvis en los 6 días siguientes a la primera dosis de medicación del estudio.
    6. Ha experimentado emesis (es decir vómitos y/o arcadas) en las 24 horas anteriores a la administración de la primera dosis de medicación del estudio.
    7. Ha presentado náuseas clínicamente significativas (ejemplo, 25mm en una EAV) en las 24 horas anteriores a la administración de la primera dosis de medicación del estudio.
    8. Presenta un tumor maligno primario o metastásico en el sistema nervioso central, a menos que haya sido tratado con éxito mediante extirpación o radiación y posteriormente haya permanecido estable al menos durante 1 semana antes de recibir la primera dosis de medicación del estudio.
    9. Tiene historia de enfermedad ulcerosa péptica documentada (a través de endoscopia o radiografía), enfermedad ulcerosa péptica activa, obstrucción gastrointestinal, carcinoma gástrico, aumento de la presión intracraneal, hipercalcemia o cualquier otra enfermedad (distinta del cáncer) que, a juicio del investigador, pueda confundir los resultados del estudio, representar otra potencial etiología para emesis y náuseas (distinta de las NVIQ) o supone un riesgo injustificado para el sujeto.
    10. Tiene hipersensibilidad o una contraindicación conocida a ZOFRAN, otro antagonista de los receptores 5-HT3, dexametasona o cualquiera de los componentes de casopitant.
    11. Ha recibido anteriormente un antagonista de los receptores NK-1.
    12. Tiene una infección sistémica activa o una enfermedad no controlada
    13. Está recibiendo o tiene previsto recibir tratamiento sistémico con corticosteroides a cualquier dosis en las 72 horas anteriores a la primera dosis de la medicación del estudio, excepto cuando estén indicados como premedicación para un taxano. Sin embargo, los esteroides tópicos y los corticosteroides inhalados con una dosis de esteroide 10mg diarios de prednisona o equivalente, están permitidos.
    14. Tiene previsto recibir un transplante de médula ósea y/o tratamiento de rescate con células madre con este ciclo de terapia con cisplatino.
    15. Ha recibido un fármaco en investigación en los 30 días o cinco semividas (lo que sea más largo) anteriores a la primera dosis de la medicación del estudio, y/o tiene previsto recibir cualquier fármaco en investigación durante el estudio.
    16. Ha recibido medicación moderadamente y/o altamente emetógena en las 48 horas anteriores a la primera dosis de la medicación del estudio. (Los narcóticos opiáceos para el tratamiento del dolor producido por el cáncer estarán permitidos si el sujeto ha estado con dicha medicación al menos durante 7 días y no ha presentado náuseas o emesis a causa de ellos).

    17. Ha tomado/recibido cualquier medicación con actividad antiemética potencial o conocida en el periodo de 24 horas anterior a la administración del fármaco del estudio. Esto incluye, pero no se limita a:
    - antagonistas de los receptores 5-HT3. El palonestrón no está permitido en los 7 días anteriores a la administración del producto en investigación.
    - benzamida/derivados de la benzamida
    - benzodiazepinas (excepto si el sujeto está recibiendo dicha medicación para dormir o para tratamiento de la ansiedad y ha estado con una dosis estable al menos durante 7 días antes de recibir la primera dosis del producto en investigación GW679769; sin embargo, el lorazepam está prohibido).
    - fenotiazinas, butirofenona, corticosteroides, anticolinérgicos, antihistamínicos, domperidoma, mirtazapina, olanzapina, cannabinoides
    18. Ha tomado/recibido potentes o moderados inhibidores del CYP3A4 y del CYP3A5
    19. Ha tomado/recibido inductores del CYP3A4 y del CYP3A5 en los 14 días anteriores a la administracióndel casopitant.
    20. Está tomando el antidiabético repaglinida o el diurético torsemida. Se aconseja a los investigadores que tengan cuidado si incluyen sujetos que estén tomando los antidiabéticos rosiglitazona o pioglitazona, o antipalúdicos como cloroquina o amodiaquina, porque el metabolito de casopitant es un potencial inhibidor del CYP2C8.
    E.5 End points
    E.5.1Primary end point(s)
    La variable primaria será la proporción de sujetos que alcanzan una respuesta completa (definida como ausencia de vómitos y arcadas y sin tratamiento de rescate) durante las 120 horas siguientes al inicio del primer ciclo de quimioterapia altamente emetógena con cisplatino
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    LSLV
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 355
    F.4.2.2In the whole clinical trial 810
    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)
    No está planeado que se ofrezca el producto en investigación a los participantes del estudio en cuando haya finalizado. GW679769 actualmente no tiene autorización de comercialización en ningún páís. Después de completar el estudio, el médico será el responsable de asegurar que el sujeto reciba los cuidados y tratamientos apropiados
    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 Decision2006-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-09
    P. End of Trial
    P.End of Trial StatusOngoing
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