Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43883   clinical trials with a EudraCT protocol, of which   7296   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-012348-18
    Sponsor's Protocol Code Number:jacobofor1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-05-08
    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 number2009-012348-18
    A.3Full title of the trial
    Artrosis de rodilla: efectos a largo plazo de magnetoterapia, sulfato de glucosamina y ácido hialurónico
    A.4.1Sponsor's protocol code numberjacobofor1
    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 SponsorJacobo Formigo Couceiro
    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 RoleComparator
    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 XICIL 1500 mg polvo para solución oral
    D.2.1.1.2Name of the Marketing Authorisation holderROTTAPHARM, S.L.
    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 nameSulfato de glucosamina
    D.3.4Pharmaceutical form Oral powder
    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 INNGLUCOSAMINA SULFATO
    D.3.9.3Other descriptive nameGLUCOSAMINE SULFATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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: efectos a largo plazo de magnetoterapia, sulfato de glucosamina y ácido hialurónico. Ensayo clínico controlado aleatorizado
    La artrosis es un problema creciente con gastos crecientes en su atención en los países industrializados.
    A pesar de esto aún no se conoce correctamente el efecto a largo plazo de muchos de los fármacos utilizados.
    Se hace necesario introducir nuevos sistemas de diagnóstico y seguimiento como la ecografía.
    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
    Comparar la eficacia de magnetoterapia, infiltraciones de ácido hialurónico y sulfato de glucosamina oral en el tratamiento de la artrosis de rodilla.
    Valorar la utilidad de la ecografía en el control de la progresión de artrosis de rodilla en relación a la radiografía convencional (grosor de cartílago).
    Establecer la concordancia clínico ecográfica.
    E.2.2Secondary objectives of the trial
    Establecer la mejoría de dolor (EVA), capacidad funcional (WOMAC e índice de Lequesne), evalución global de paciente y médico, progresión de enfermedad (RX y ECO) con magnetoterapia, sulfato de glucosamina y ácido hialurónico.
    Determinar la influencia de magnetoterapia, infiltraciones con ácido hialurónico y sulfato de glucosamina oral en la evolución de los parámetros de marcha (velocidad de marcha, número de pasos, patrón de marcha).
    Determinar la influencia de los factores de riesgo reconocidos en la progresión de la enfermedad en cada grupo de tratamiento.
    Calcular coste directo de los diferentes tratamientos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes que llegan al Servicio de Rehabilitación del Complexo Hospitalario de Ourense (CHOU) desde el servicio de traumatología y desde atención primaria.
    Se incluyen todos los pacientes con diagnóstico clínico radiológico de artrosis de rodilla primaria según los criterios del American College of Rheumatology modificados por Hochberg y cols. en 1995:
    - Formato tradicional: dolor de rodillas y osteofitos radiográficos y al menos uno de los 3 items=
    + Edad menor de 50 años.
    + Rigidez matutina menor o igual a 30 minutos.
    + Crepitación al movimiento.
    - Clasificación en árbol:
    + Dolor en rodilla y osteofitos radiográficos o
    + Dolor de rodilla y edad igual o mayor de 40 años y rigidez matutina menor o igual de 30 minutos y crepitación al movimiento.
    Se realiza según las recomendaciones de la American College of Rheumatology una analítica inicial con VSG (<40mm/hr) y FR (<1:40) para descartar posible alteración artrítica y no artrósica.
    E.4Principal exclusion criteria
    Se excluyen: embarazadas, pacientes con enfermedades sistémicas severas que produzcan un compromiso vital o severo de la inmunidad, paciente con enfermedad inflamatoria articular activa, pacientes en situación de demanda de incapacidad, pacientes con contraindicación para aplicación de alguna de las terapias a aplicar, pacientes con tratamiento corticoideo intrarticular en los tres meses previos a la inclusión en el estudio o AINE o corticoide oral en los 14 días previos al comienzo del estudio y los pacientes que hubieran participado en un ensayo de algún fármaco en investigación en los 30 días anteriores a la primera visita.
    E.5 End points
    E.5.1Primary end point(s)
    Sexo, edad, clasificación radiológica de Kellgren y Lawrence, índice de masa corporal (IMC), duración de la sintomatología en meses, uni o bilateralidad, actividad física (> 4 horas/día), alineación de miembro inferior (grados de desviación varo o valgo), antecedente de daño articular (menistectomía o rotura ligamento cruzado anterior), balance articular con goniómetro (flexión y extensión), consumo de medicación de rescate, EVA, índice Lequesne, WOMAC, evaluación global de paciente y médico, efectos adversos, valores ECO (derrame articular, claridad cartílago, integridad interfase, grosor cartílago), RX (espacio articular), abandonos y exclusión del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Magnetoterapia
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    El final del ensayo se producirá cuando finalice el 3º año, trascurridos 2 años del últimos paciente incluido.
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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 Decision2009-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 21 01:19:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA