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    Summary
    EudraCT Number:2009-015527-82
    Sponsor's Protocol Code Number:GRT-CG5503-2009-01-ES
    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:2009-10-07
    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 number2009-015527-82
    A.3Full title of the trial
    Estudio abierto de extensión para los pacientes con lumbalgia crónica severa o dolor crónico severo debido a artrosis de rodilla que han completado alguno de los ensayos clínicos previos de fase IIIb de clorhidrato de tapentadol códigos KF5503/42, KF5503/43, KF5503/44 o KF5503/45.
    A.4.1Sponsor's protocol code numberGRT-CG5503-2009-01-ES
    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 SponsorGrünenthal Pharma 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 nameTapentadol 50 mg comprimidos recubiertos con pelicula
    D.3.2Product code CG5503
    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.3.8INN - Proposed INNClorhidrato de Tapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive name3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.8Extractive medicinal product No
    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 nameTapentadol 50 mg comprimidos de liberación prolongada
    D.3.2Product code CG5503
    D.3.4Pharmaceutical form Prolonged-release 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 INNClorhidrato de Tapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive name3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.8Extractive medicinal product No
    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 nameTapentadol 100 mg comprimidos de Liberación Prolongada
    D.3.2Product code CG5503
    D.3.4Pharmaceutical form Prolonged-release 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 INNClorhidrato de Tapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive name3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 No
    D.3.11.8Extractive medicinal product No
    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 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 nameTapentadol 150 mg comprimidos de Liberación Prolongada
    D.3.2Product code CG5503
    D.3.4Pharmaceutical form Prolonged-release 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 INNClorhidrato de Tapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive name3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.8Extractive medicinal product No
    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 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 nameTapentadol 200 mg comprimidos de Liberación Prolongada
    D.3.2Product code CG5503
    D.3.4Pharmaceutical form Prolonged-release 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 INNClorhidrato de Tapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive name3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.8Extractive medicinal product No
    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: 6
    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 nameTapentadol 250 mg comprimidos de Liberación Prolongada
    D.3.2Product code CG5503
    D.3.4Pharmaceutical form Prolonged-release 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 INNClorhidrato de Tapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive name3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol-hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Artrosis de rodilla y lumbalgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10024891
    E.1.2Term Low back pain
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ofrecer tratamiento con clorhidrato de tapentadol a pacientes que han completado los ensayos clínicos KF5503/42, KF5503/43, KF5503/44 o KF5503/45 y que podrían beneficiarse del tratamiento analgésico continuado con tapentadol.
    E.2.2Secondary objectives of the trial
    ? Evaluar la eficacia, tolerabilidad y seguridad a largo plazo del tratamiento continuado con clorhidrato de tapentadol en pacientes con lumbalgia crónica severa o dolor crónico severo debido a artrosis de rodilla que hayan completado los ensayos clínicos KF5503/42, KF5503/43, KF5503/44 o KF5503/45.
    ? Evaluar el efecto ahorrador a largo plazo de clorhidrato de tapentadol sobre los analgésicos de Escalón I y los coanalgésicos en pacientes que redujeron o dejaron de tomar estos fármacos durante el Subestudio A del protocolo precedente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión principales (generales)

    1. Pacientes que firmen el Consentimiento Informado atestiguando que entienden los objetivos y los procedimientos del estudio y expresando su deseo de participar en él.
    2. Pacientes varones o mujeres no embarazadas ni en periodo de lactancia. Las mujeres fértiles con vida sexual activa deberán haber pasado la menopausia, haber recibido esterilización quirúrgica o seguir un método anticonceptivo eficaz (p. ej. anticonceptivos orales bajo prescripción médica, inyecciones anticonceptivas, dispositivos intrauterinos, métodos de doble barrera, parches anticonceptivos, esterilización de su pareja) antes de la inclusión y durante todo el estudio. Las mujeres fértiles deberán tener un resultado negativo en la última prueba de embarazo realizada durante el protocolo precedente.
    3. Pacientes con capacidad para verbalizar y discriminar los datos de localización e intensidad del dolor.
    4. Compromiso de no recibir ningún otro Medicamento en Investigación diferente de clorhidrato de tapentadol durante todo el periodo de protocolo de Extensión; es decir, no participar en ningún otro estudio clínico que implique la administración de un Medicamento en Investigación ni el empleo de un dispositivo experimental.

    Criterios de inclusión principales (específicos del estudio)

    5. Pacientes que completen el Periodo de Continuación (Semanas 9 a 12) de alguno de los protocolos precedentes KF5503/42, KF5503/43, KF5503/44 o KF5503/45 sin haber presentado ninguna violación mayor del protocolo.
    6. Pacientes que hayan cumplido el objetivo mínimo de la titulación en el protocolo precedente y que lo continúen cumpliendo en la Visita Basal del presente protocolo de Extensión.
    7. Pacientes quienes, en opinión del Investigador, podrían beneficiarse del tratamiento continuado con clorhidrato de tapentadol para su lumbalgia crónica severa (estudios KF5503/44 y KF5503/45) o para el dolor crónico severo debido a artrosis de rodilla (estudios KF5503/42 y KF5503/43).
    E.4Principal exclusion criteria
    Criterios de exclusión principales (generales)

    1. Antecedentes o sospecha, a juicio del Investigador, de abuso de drogas o alcohol.
    2. Presencia de patologías inflamatorias de origen autoinmune concomitantes.
    3. Antecedentes conocidos o hallazgos analíticos que indiquen insuficiencia renal grave (a confirmar cuando los resultados de la muestra de la Visita 12 del protocolo precedente estén disponibles).
    4. Antecedentes conocidos de insuficiencia hepática moderada o grave (a confirmar cuando los resultados de la muestra de la Visita 12 del protocolo precedente estén disponibles).
    5. Antecedentes de hepatitis B o C crónica o activa durante los 3 meses anteriores o antecedentes de infección por VIH.
    6. Antecedentes de trastornos convulsivos o epilepsia.
    7. Cualquiera de los siguientes durante el año anterior: traumatismo encefálico leve/moderado, ictus, accidente isquémico transitorio, o neoplasia cerebral. Traumatismo encefálico grave en los 15 años anteriores (con presencia de uno o más de los siguientes: contusión cerebral, hematoma intracraneal, o inconsciencia o amnesia postraumática durante más de 24 horas) o secuelas residuales que sugieran modificaciones transitorias del estado de consciencia.
    8. Mujeres embarazadas o en periodo de lactancia.
    9. Contraindicación o antecedentes de alergia o hipersensibilidad a clorhidrato de tapentadol, incluyendo:
    ? Pacientes con asma bronquial agudo o severo o hipercapnia.
    ? Pacientes con íleo paralítico, sospechado o confirmado.
    ? Pacientes con depresión respiratoria sospechada o confirmada.
    10. Empleados del Investigador o del Centro del estudio, con relación directa con el presente estudio o con otros estudios bajo la dirección del mismo Investigador o Centro del estudio, así como familiares de los empleados o del Investigador.
    11. Participación simultánea en otro ensayo clínico.
    12. Incapacidad, o sospecha de ésta, para cumplir el protocolo del estudio o para el uso de los Medicamentos en Investigación.
    13. Toma de inhibidores de la monoaminooxidasa.
    14. Toma de inhibidores selectivos de la recaptación de serotonina con dosis no estables (las dosis deben permanecer estables durante todo el estudio).

    Criterios de exclusión principales (específicos del estudio)

    15. Abandono prematuro del tratamiento con clorhidrato de tapentadol durante el estudio precedente por cualquier motivo.
    16. Los pacientes deben continuar cumpliendo todos los demás criterios de exclusión específicos del protocolo precedente, a excepción (sólo para los pacientes provenientes de los estudios KF5503/42 y KF5503/43) del criterio de exclusión específico 17 (artrosis en estado de brote) para poder entrar en el protocolo de Extensión.
    E.5 End points
    E.5.1Primary end point(s)
    sólo se realizará un análisis descriptivo de las evaluaciones que se mencionan a continuación, y no se ha definido un criterio principal de eficacia.
    Criterios de eficacia y de evaluaciones de calidad de vida
    ? Puntuación promedio en la NRS-3 de 11 puntos en cada visita.
    ? Impresión Clínica Global de Cambio según el paciente (ICGP).
    ? Impresión Clínica Global de Cambio según el médico (ICGC).
    ? Ítems del Cuestionario de Evaluación del Sueño (CS).
    ? Satisfacción del paciente con el tratamiento.
    ? Puntuaciones del EuroQoL 5 Dimensiones (EQ 5D).
    ? Puntuaciones de la Encuesta de Salud Abreviada (SF 36®).
    ? Necesidad de incrementos de la dosis de clorhidrato de tapentadol LP.
    ? Posibilidad de reducir las dosis de analgésicos concomitantes del Escalón I o de los co-analgésicos.
    Para pacientes provenientes de los estudios KF5503/42 y KF5503/43:
    ? Puntuaciones con el Cuestionario de las universidades Western Ontario y McMaster (WOMAC).
    Para pacientes provenientes de los estudios KF5503/44 y KF5503/45 y que presenten un resultado ?dudoso? o ?positivo? sobre el componente neuropático en el cuestionario painDETECT en la Visita Basal del protocolo precedente:
    ? Puntuación promedio en la NRS-3 de 11 puntos sobre el dolor en la pierna o irradiado hacia la pierna.
    ? SF-MPQ.
    ? NPSI.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned10
    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 Information not present in EudraCT
    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
    última visita del último paciente o hasta la comercialización del producto
    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 months11
    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 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 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 state128
    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)
    NA
    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 Decision2009-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-14
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