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    Summary
    EudraCT Number:2008-002171-27
    Sponsor's Protocol Code Number:METILÁS09/2008
    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:2008-06-27
    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 number2008-002171-27
    A.3Full title of the trial
    ENSAYO CLÍNICO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA DEL TRATAMIENTO PALIATIVO CON METILFENIDATO EN ASTENIA (DE PACIENTES CON CÁNCER AVANZADO).
    A.3.2Name or abbreviated title of the trial where available
    METILAS 09
    A.4.1Sponsor's protocol code numberMETILÁS09/2008
    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 SponsorInstituto Científico y Tecnológico de Navarra, SA. (ICT).
    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 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 Yes
    D.2.1.1.1Trade name RUBIFEN 10 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS RUBIO, 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.3.4Pharmaceutical form Compressed lozenge
    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 INNMETILFENIDATO HIDROCLORURO
    D.3.9.1CAS number 298-59-5
    D.3.9.3Other descriptive nameMETHYLPHENIDATE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCompressed lozenge
    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
    Astenia en pacientes con cáncer avanzado.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003549
    E.1.2Term Asthenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Determinar la eficacia del Metilfenidato en el tratamiento de astenia en una población de enfermos con cáncer avanzado.
    -Determinar la eficacia de Metilfenidato en la astenia de pacientes con cáncer avanzado entendiendo que esta eficacia será probada si la diferencia de proporción en la respuesta positiva entre el grupo tratado con Metilfenidato y el tratado con placebo es de al menos el 30 % de los sujetos.
    -La respuesta (mejoría sintomática en la astenia) será medida con una EVN de debilidad incluida en el Edmonton System Assesment Scale (ESAS). Se considerará respuesta positiva una mejoría ? 2 puntos sobre el nivel previo de astenia medido en la EVA de 0 a 10 (0: nada débil, 10: la mayor debilidad posible de imaginar).
    E.2.2Secondary objectives of the trial
    -Estudiar la evolución de la astenia en la respuesta de dos grupos de tratamiento según las puntuaciónes totales obtenidas con la subescala de astenia del Functional Assesment of Cancer Therapy (FACT-F).
    -Explorar aspectos particulares de la astenia de pacientes con cáncer avanzado susceptibles de mejoría con el tratamiento activo mediante la comparación de respuestas a cada uno de los diferentes ítems de FACT-F
    -Determinar la evolución de otros síntomas concomitantes a la astenia medidos con ESAS en ambos grupos de tratamiento
    -Comparar la validez de medida de la astenia con los dos diferentes instrumentos de medida del estudio: EVN y FACT-F
    -Identificar la aparición de efectos adversos relacionados con el tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Paciente de 18 ó más años.
    2.Paciente con cáncer avanzado, incluyendo cáncer metastático, localmente avanzado o en recidiva, sin opción de tratamiento de intención radical.
    3.Paciente con Mini-Mental en límites normales para su edad y escolaridad.
    4.Paciente que otorgan su consentimiento informado.
    5.Paciente con esperanza de vida de un mes o mayor a criterio del médico investigador.
    6.Paciente con Hemoglobina ?9.
    7.Paciente que puntúa ?4 en EVN de ?debilidad?.
    E.4Principal exclusion criteria
    1.Pacientes con antecedentes de psicosis.
    2.Pacientes que presentan ideas suicidas acompañadas de un plan estructurado y factible a criterio del médico investigador.
    3.Pacientes con ansiedad severa.
    4.Pacientes con historia de drogadicción o abuso de psicofármacos.
    5.Pacientes con contraindicación médica como insuficiencia hepática o renal grave severa, historia de cardiopatía severa (arritmias, angor, hipertensión grave) o antecedente de convulsiones.
    6.Pacientes que toman otros medicamentos con los cuales se contraindica Metilfenidato: cumarínicos, anticonvulsivantes (fenobarbital, fenitoína, primidona), fenilbutazona, iMAO, guanetidina.
    7.Pacientes con antecedentes de glaucoma.
    8.Pacientes con hipertiroidismo.
    9.Pacientes con antecedentes de hipersensibilidad al Metilfenidato.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal será el nivel de astenia de valorado mediante una Escala Visual Numérica (EVN) incluida dentro del cuestionario de evaluación de Síntomas de Edmonton (ESAS).
    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 Yes
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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.8.3 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 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
    Se entenderá por final del ensayo como el momento a partir del cual no se reclutan nuevos paciente y todos los enrolados concluyen su seguimiento.
    Figura en protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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 Yes
    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 state80
    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)
    En protocolo.
    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 Decision2008-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-07
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