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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-005759-13
    Sponsor's Protocol Code Number:BO-EC-DEM-02
    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:2010-03-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2006-005759-13
    A.3Full title of the trial
    Ensayo clínico multicéntrico, aleatorizado, con grupos paralelos, controlado con placebo y doble ciego, para valorar la eficacia del tratamiento con 320 mg al día de Acetato de Megestrol durante 24 semanas en la pérdida de peso de pacientes con Demencia primaria y mixta.
    A.4.1Sponsor's protocol code numberBO-EC-DEM-02
    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 SponsorMADAUS, 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 Yes
    D.2.1.1.1Trade name BOREA Sobres
    D.2.1.1.2Name of the Marketing Authorisation holderMADAUS, 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 Granules for oral suspension
    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.3.9.3Other descriptive nameACETATO DE MEGESTROL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 placeboGranules for oral suspension
    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
    Pacientes diagnosticados de demencia (Criterios CIE 10) y clasificados etiológicamente como demencia primaria o mixta, con pérdida de peso y/o malnutrición proteicocalórica.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012267
    E.1.2Term Dementia
    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 principal es evaluar el cambio en el peso de los pacientes con Demencia primaria y mixta.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son evaluar:
    1. Cambio en el apetito.
    2. Cambio en los marcadores antropométricos.
    3. Cambio en los marcadores bioquímicos.
    4. Cambio en el estado nutricional.
    5. Cambio en la actividad de la vida diaria (AVD).
    6. Cambio en el estado cognitivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.1. Pacientes masculinos o femeninos ³ 65 años.
    2. Pacientes diagnosticados de demencia (Criterios CIE 10) y clasificados etiológicamente como demencia primaria o mixta.
    3. Pacientes con pérdida de peso superior al 5% del peso habitual en los últimos 6 meses (evaluado por interrogatorio) y una malnutrición proteico-calórica definida con un resultado en el cuestionario Mini Nutritional Assessment < 17.
    4. Esperanza de vida > 6 meses.
    5. Pacientes visitados en régimen ambulatorio, en consultas externas hospitalarias, o de hospital de día evaluador, con capacidad suficiente para la deambulación. En caso de que durante el estudio el paciente ingresara en un hospital de media o larga estancia, sólo se retirará del estudio si el ingreso fuera en una institución ajena a los investigadores y no se pudiera realizar el seguimiento y/o el paciente tuviese que ser encamado.
    6. Si siguen un tratamiento con fármacos anticolinesterásicos, deben haber transcurrido más de 3 meses desde haber alcanzado el nivel de dosis estable. Si siguen un tratamiento con memantina, debe haber transcurrido más de 1 mes desde haber alcanzado el nivel de dosis estable.
    7. Conformidad del tutor para que el paciente participe en el estudio.
    E.4Principal exclusion criteria
    1. Demencia vascular pura y demencias secundarias.
    2. Demencia en fase terminal: categoría FAST 7c en la escala de Reisberg, además de presentar al menos una de las siguientes condiciones: dificultad deglutoria, neumonía por aspiración, deshidratación, infección urinaria severa, úlceras por presión, septicemia.
    3. Portador de sonda nasogástrica.
    4. Presencia de bulimia.
    5. Carcinoma de mama o de los órganos reproductores.
    6. Hemorragia vaginal anómala sin diagnosticar.
    7. Antecedentes de tromboflebitis, tromboembolismo pulmonar, enfermedades cerebrovasculares y trombosis retinal en el último año.
    8. Disfunción o enfermedad hepática (bilirrubina total > 1.25 x LSN; transaminasas > 1.5 x LSN).
    9. Disfunción renal (creatinina > 1.5 x LSN).
    10. Diabetes mellitus no controlada.
    11. HTA o insuficiencia cardíaca congestiva no controlada(s).
    12. Ascitis.
    13. Obstrucción mecánica del tracto gastrointestinal.
    14. Infecciones sistémicas no tratadas u otras enfermedades intercurrentes graves.
    15. Tratamiento concomitante con esteroides, andrógenos u otros fármacos que contengan progestágenos. Se permite el uso de corticoides inhalados a lo largo de todo el estudio.
    Se permite el tratamiento puntual con corticoides vía oral en caso agudo siempre y cuando se termine dicho tratamiento 8 semanas antes de la siguiente extracción sanguínea para la determinación de parámetros de laboratorio.
    16. Pérdida de peso secundaria a una malnutrición enteral (enfermedad celíaca, enfermedad de Crohn, cirugía postgástrica, etc.).
    17. Pérdida de peso secundaria a un hipertiroidismo.
    18. Pérdida de peso secundaria a una enfermedad pulmonar obstructiva crónica (EPOC).
    19. Pérdida de peso debido a una insuficiencia suprarrenal primaria (Enfermedad de Addison).
    20. Pérdida de peso secundaria a enfermedad neoplásica.
    21. Intolerancia a la lactosa demostrada o manifiesta.
    22. Sujetos en los que exista una alta probabilidad de que no pueda ser medido el criterio de evaluación.
    23. Tratamiento con AM en los últimos 6 meses antes de la inclusión en este estudio
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia será el peso (en kilogramos). Se considerará clínicamente significativa una ganancia mayor o igual a 5% del peso en la semana 24 respecto al peso habitual en la visita basal.
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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.8.3 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 concerned11
    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
    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 months
    E.8.9.1In the Member State concerned days
    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) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pacientes con Demencia primaria y mixta.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state220
    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 Decision2007-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
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