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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2004-000485-13
    Sponsor's Protocol Code Number:2003100 - HMR4003I/3001
    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:2006-06-27
    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 number2004-000485-13
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico y de grupos paralelos de un año de duración, seguido de 2 años de tratamiento abierto para determinar la seguridad y eficacia de Risedronato diario 2,5 mg o 5,0 mg administrado oralmente en niños ³ 4 a < 16 años con osteogénesis imperfecta.
    A.3.2Name or abbreviated title of the trial where available
    POISE
    A.4.1Sponsor's protocol code number2003100 - HMR4003I/3001
    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 SponsorProcter & Gamble Ltd
    B.1.3.4CountryUnited Kingdom
    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 Information not present in EudraCT
    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 namerisedronato sódico 2.5mg
    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 INNácido risedrónico
    D.3.9.1CAS number 115436-72-1
    D.3.9.2Current sponsor codeNE-58095
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Information not present in EudraCT
    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 nameRisedronato sódico 5mg
    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 INNácido risedrónico
    D.3.9.1CAS number 115436-72-1
    D.3.9.2Current sponsor codeNE-58095
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Osteogenesis Imperfecta
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es determinar la eficacia de risedronato en comparación con placebo en niños ≥ 4 a < 16 años de edad con osteogénesis imperfecta (OI) evaluada por el porcentaje de cambio respecto a la Basal en la densidad mineral ósea (DMO) de la columna lumbar en el Mes 12.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son:
    a) evaluar la eficacia de risedronato en comparación con placebo en niños ≥ 4 a < 16 años de edad con OI.

    b) evaluar la seguridad y tolerabilidad del tratamiento con risedronato en niños ≥ 4 a < 16 años de edad con OI

    Periodo del estudio abierto (Segundo y Tercer año del estudio)

    Los objetivos secundarios son evaluar el tratamiento con risedronato en niños ≥ 4 a < 16 años de edad con OI
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Para ser elegibles en este estudio, un niño debe cumplir lo siguiente:
    a) diagnóstico de OI en base a una escala de clasificación modificada7,8 (Apéndice I)
    b) edad de 4 a 15 años (≥4 a <16), inclusive
    c) tener un riesgo elevado de fracturas definido por:
    • antecedentes de al menos 1 fractura confirmada radiológicamente, no traumática o de bajo impacto, más DMO baja (puntuación Z ≤ -1 en puntos de cuerpo entero o columna lumbar);
    o
    • DMO muy baja (puntuación Z ≤ -2,0 en puntos de cuerpo entero o columna lumbar) con o sin antecedentes de fracturas
    d) tener al menos 2 cuerpos vertebrales de columna lumbar evaluables (L1-L4), es decir sin fractura o enfermedad degenerativa
    e) si es niña, post-menarquia y sexualmente activa, debe aceptar utilizar un sistema anticonceptivo fiable durante todo el estudio. Formas aceptables de anticonceptivos incluyen anticonceptivos orales, inyectados o implantados, o dispositivos intrauterinos.
    f) si es niña y post-menarquia, debe presentar una prueba de embarazo negativa en suero y orina en la Selección
    g) ser capaz y que quiera participar en el estudio evidenciado mediante la firma del padre/representante legal de un consentimiento informado por escrito y la firma del paciente de un asentimiento (si apropiado).
    E.4Principal exclusion criteria
    Un niño no será elegible para este estudio si cumple alguno de los siguientes:
    a) peso < 10 kg
    b) antecedentes de cáncer en los 5 años anteriores
    c) raquitismo no tratado en el plazo de 1 año antes del reclutamiento
    d) antecedentes de alteraciones orgánicas o psiquiátricas o de hallazgos en la exploración física clínicamente significativos, que en opinión del Investigador, pueda evitar que el paciente finalice el estudio
    e) antecedentes documentados de una reacción anormal o alérgica a bisfosfonatos
    f) abuso de alcohol
    g) abuso de prescripción de drogas ilegales
    h) antecedentes de uso de las siguientes medicaciones, independientemente de la dosis, durante al menos 1 mes, en los 3 meses previos al reclutamiento:
    • agentes anabólicos
    • estrógenos (excepto anticonceptivos)
    • progestágenos (excepto anticonceptivos)
    • calcitriol, calcidiol, o alfacalcidiol
    • calcitonina
    • fluor (excepto productos de salud dental)
    • glucocorticoides (no incluye glucocorticoides inhalados)
    • hormonas de crecimiento
    • hormona paratifoidea (PTH)
    • estroncio
    i) antecedentes de uso de cualquier bisfosfonato en el plazo de 1 año antes del reclutamiento, excepto para una dosis única de bisfosfonato oral, como risedronato o alendronato
    j) osteoporosis, secundaria a otras enfermedades aparte de OI o tratamientos farmacológicos
    k) hallazgo de laboratorio anormal clínicamente significativo, como sigue:
    • prueba de función pulmonar (PFP), AST o ALT > 2 x LSN
    • hormona estimuladota del tiroides (TSH) y PTH fuera del rango de referencia normal
    Nota: Una concentración de PTHi fuera del límite inferior del rango de normalidad se puede asociar con suplemento de calcio. En consecuencia, el Investigador y el Monitor Médico revisarán los datos personales y la historia clínica del paciente para confirmar o rechazar que la concentración de PTHi baja esté asociada con elevado suplemento de calcio para determinar si el paciente es elegible para entrar en este estudio. A los pacientes con concentraciones de PTHi bajas por cualquier razón no se les permitirá participar en este estudio. Estas discusiones en relación con la elegibilidad se documentarán en un informe de contacto.
    • vitamina D 25-OH en suero < 20 mmol/L (8 ng/mL)
    • creatinina en suero > 106 micromol/L (1,2 mg/dL)
    l) uso actual de medicación anticonvulsiva
    m) uso actual de medicación anticoagulante
    n) participación en otro ensayo clínico en los 3 meses previos al reclutamiento
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es el porcentaje de cambio desde el basal en DMO en la columna lumbar a los doce meses.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    seguiemto del periodo abierto.
    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.8.5The 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
    Por favor, consultar la sección 5.4 en el protocolo del estudio.
    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 days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Trial subjects are under 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 124
    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 Decision2006-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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