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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2011-000245-20
    Sponsor's Protocol Code Number:FSJD-RAL-2010
    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:2012-01-24
    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 number2011-000245-20
    A.3Full title of the trial
    ENSAYO CLÍNICO DOBLE CIEGO A SEIS MESES, CONTROLADO CON PLACEBO, DE LA EFICACIA DE RALOXIFENO COMO TRATAMIENTO ADYUVANTE DE LOS SÍNTOMAS NEGATIVOS DE LA ESQUIZOFRENIA, EN MUJERES POSTMENOPÁUSICAS

    "A 6-month double-blind, placebo-controlled study of efficacy of raloxifene as an adjuvant treatment for negative symptoms of schizophrenia in postmenopausal women."
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ENSAYO CLÍNICO DOBLE CIEGO A SEIS MESES, CONTROLADO CON PLACEBO, DE LA EFICACIA DE RALOXIFENO COMO TRATAMIENTO ADYUVANTE DE LOS SÍNTOMAS NEGATIVOS DE LA ESQUIZOFRENIA, EN MUJERES POSTMENOPÁUSICAS
    A.4.1Sponsor's protocol code numberFSJD-RAL-2010
    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 SponsorFUNDACIÓ SANT JOAN DE DEU
    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 supportMinisterio de Sanidad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓ SANT JOAN DE DEU
    B.5.2Functional name of contact pointRosa María Morales
    B.5.3 Address:
    B.5.3.1Street AddressC/Sant Rosa,39-57, 4ª planta,
    B.5.3.2Town/ cityEsplugas de Llobregat/ Barcelona
    B.5.3.3Post code08950
    B.5.3.4CountrySpain
    B.5.4Telephone number936009751
    B.5.5Fax number936009771
    B.5.6E-mailrmorales@fjd.org
    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 OPTRUMA 60 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    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.3.1Product nameOPTRUMA 60 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNRALOXIFENO HIDROCLORURO
    D.3.9.3Other descriptive nameRALOXIFENE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) 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 No
    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 placeboCapsule
    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
    SINTOMAS NEGATIVOS EN ESQUIZOFRENIA
    E.1.1.1Medical condition in easily understood language
    SÍNTOMAS ESQUIZOFRENIA
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 del ensayo clínico es evaluar la eficacia del raloxifeno (SERM Selective Estrogen Receptor Modulator, Modulador Selectivo de los Receptores de Estrógeno) como adyuvante del tratamiento antipsicótico, en el manejo de los síntomas negativos de la esquizofrenia en mujeres postmenopáusicas.
    E.2.2Secondary objectives of the trial
    1. Evaluar la eficacia del raloxifeno como adyuvante del tratamiento antipsicótico, en el manejo de los síntomas globales de la esquizofrenia en mujeres postmenopáusicas.
    2. Evaluar la eficacia del raloxifeno como adyuvante del tratamiento antipsicótico, en el funcionamiento global de las mujeres postmenopáusicas con esquizofrenia.
    3. Evaluar la eficacia del raloxifeno como adyuvante del tratamiento antipsicótico, en el funcionamiento neuropsicológico de las mujeres postmenopáusicas con esquizofrenia.
    4. Controlar la respuesta al tratamiento en función de las variantes genéticas del tipo SNP (del inglés Single Nucleotide Polymorphism) que las pacientes presenten en los genes de los receptores estrogénicos alfa (ESR1) y beta (ESR2).
    5. Evaluar la seguridad de la medicación empleada en esta población de pacientes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-estudio genético que tiene como objetivo evaluar el además de valorar la influencia de los polimorfismos genéticos en la respuesta al tratamiento. Se adjunta aparte(HIP_CI_GENETICO_FSJD-RAL-10_VERSIÓN 1.0_18/01/2011).
    E.3Principal inclusion criteria
    1. Diagnóstico de esquizofrenia según criterios DSM-IV TR.
    2. Pacientes postmenopáusicas. Se define postmenopausia como 1) mayor de 45 años y niveles de FSH mayores de 20 UI/L ó 2) mayor de 50 años con al menos un año de amenorrea.
    3. Pacientes que estén tomando una dosis estable de medicación antipsicótica durante al menos los 30 días previos al inicio del estudio.
    4. Presencia de síntomas negativos significativos (definidos como uno o más síntomas negativos con una gravedad de más de 4 en la escala PANSS)
    5. Consentimiento informado general por escrito de las pacientes o su representante legal.
    6. Para la realización del estudio genotípico, las pacientes o su representante legal deberán otorgar un consentimiento informado específico para ello.
    E.4Principal exclusion criteria
    1.Diagnóstico de trastorno por abuso/dependencia de sustancias en los 6 meses previos.
    2. Retraso mental
    3. Diagnóstico de depresión mayor (según los criterios del DSM-IV TR).
    4. Alteraciones endocrinas, enfermedad hepatica aguda o crónica, alteración renal.
    5. Historial o patología actual de tromboembolismo, cáncer de mama, sangrado uterino anormal o accidente cerebrovascular.
    6. Pacientes en terapia hormonal sustitutiva.
    7. Alergia o hipersensibilidad conocida al principio activo del fármaco en investigación, a cualquiera de sus excipientes o a la lactosa.
    8. Tratamiento en otro ensayo clínico.
    9. Cualquier enfermedad concomitante grave que en la opinión del investigador pueda comprometer completar el estudio o afectar la tolerancia del paciente para este tratamiento.
    10.Embarazo.
    E.5 End points
    E.5.1Primary end point(s)
    La variable primaria de eficacia será el cambio en la puntuación de la subescala negativa de la PANSS desde el inicio del tratamiento, a la valoración a las 24 semanas.
    Se comparará las puntuaciones al inicio y a la finalización del tratamiento.
    Se considerará respuesta al tratamiento como una reducción en la puntuación de la subescala negativa de la PANSS de al menos el 20% desde el inicio del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    valoración a las 24 semanas
    E.5.2Secondary end point(s)
    Se recogerán las siguientes variables secundarias, desde el inicio del tratamiento a la valoración de seguimiento, que será a las 4,12 y 24 semanas para las escalas, y únicamente a las 12 y 24 semanas para los tests neuropsicológicos:
    1. Cambio en las puntuaciones de la escala SANS.
    2. Cambio en las puntuaciones de la escala PANSS positiva, general y total.
    3. Cambio en la severidad de la escala CGI de la enfermedad.
    4. Valoración de todas las demás escalas y tests neuropsicológicos empleados.
    5. Valoración de la proporción de pacientes que han experimentado acontecimientos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    a las 12 y 24 semanas para los tests neuropsicológicos:
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.2.4Number of treatment arms in the trial2
    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
    LA VISITA DEL ÚLTIMO PACIENTE, SERA EL FINAL DEL ESTUDIO
    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 months8
    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 months0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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)
    NO APLICA
    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 Decision2011-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
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