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    Summary
    EudraCT Number:2013-000444-26
    Sponsor's Protocol Code Number:TM-CS+SG/301
    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:2013-04-09
    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 number2013-000444-26
    A.3Full title of the trial
    Phase III clinical trial to evaluate the efficacy and safety of chondroitin sulphate and glucosamine sulphate in combination versus placebo in patients with osteoarthritis of the knee.
    Ensayo clínico fase III para evaluar la eficacia y seguridad de una asociación de condroitín sulfato y glucosamina sulfato frente a placebo en pacientes con artrosis de rodilla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Confirmatory study to evaluate the efficacy and safety of chondroitin sulphate and glucosamine sulphate in combination in the treatment of patients with osteoarthritis of the knee compared to placebo.
    Estudio confirmatorio para evaluar la eficacia y seguridad de una asociación de condroitín sulfato y glucosamina sulfato en el tratamiento de pacientes con artrosis de rodilla en comparación con placebo.
    A.4.1Sponsor's protocol code numberTM-CS+SG/301
    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 SponsorTedec-Meiji Farma, 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 supportTedec-Meiji Farma, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTedec-Meiji Farma, S.A.
    B.5.2Functional name of contact pointDepartamento Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressCtra. M-300, Km. 30,500
    B.5.3.2Town/ cityAlcalá de Henares
    B.5.3.3Post code28802
    B.5.3.4CountrySpain
    B.5.4Telephone number34918870980
    B.5.5Fax number34918830446
    B.5.6E-mailm.gimeno@tedecmeiji.com
    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 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 nameAsociación de condroitín sulfato y glucosamina sulfato
    D.3.2Product code CS+SG
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNCHONDROITIN SULPHATE SODIUM
    D.3.9.2Current sponsor codeCS
    D.3.9.3Other descriptive nameCondroitín sulfato de sodio
    D.3.9.4EV Substance CodeSUB13356MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLUCOSAMINE SULFATE POTASSIUM CHLORIDE
    D.3.9.2Current sponsor codeSG
    D.3.9.3Other descriptive nameSulfato de glucosamina cloruro potásico
    D.3.9.4EV Substance CodeSUB26636
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboPowder for oral solution
    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
    Knee osteoarthritis.
    Artrosis de rodilla.
    E.1.1.1Medical condition in easily understood language
    Knee osteoarthritis.
    Artrosis de rodilla.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of a combination of chondroitin sulphate and glucosamine sulphate manufactured by Tedec-Meiji Farma, S.A. compared with placebo in patients with osteoarthritis of the knee.
    Valorar la eficacia de la asociación de condroitín sulfato y glucosamina sulfato fabricada por Tedec-Meiji Farma, S.A. comparada frente a placebo en pacientes con artrosis de rodilla.
    E.2.2Secondary objectives of the trial
    To assess the safety of treatment.
    Valorar la seguridad del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged at 45 or more years old, of both sexes.
    Primary knee OA according to ACR criteria.
    Osteoarthritis radiological grade II-III according to Kellgren and Lawrence scale.
    Patients with moderate-severe pain (from 40-80 mm) in Visual Analogue Scale (VAS) during last week of the most symptomatic knee.
    Patient able to understand and follow study procedures, also to willingness to adhere to treatment.
    Patient who agrees to participate in the study by giving his/her written informed consent.
    Paciente de 45 o más años de edad, de ambos sexos.
    Artrosis primaria de rodilla de acuerdo con criterios ACR.
    Grado radiológico de artrosis II-III según la escala Kellgren y Lawrence.
    Pacientes con dolor moderado a severo (de 40-80 mm) en la Escala Visual Analógica (EVA) durante la semana previa a la evaluación en la rodilla más sintomática.
    Paciente con capacidad para comprender y seguir los procedimientos del estudio y disposición para adherirse al estudio.
    Conformidad para participar en el estudio otorgando su consentimiento por escrito.
    E.4Principal exclusion criteria
    Overweight (body mass index greater than or equal 35).
    Pregnant or lactating women. Women of child-bearing age not using effective contraception.
    Predominant patellofemoral disease.
    Patients with clinical significant trauma or surgery in the target knee.
    Administration of NSAIDs within the 14 days prior to the inclusion in the study.
    Administration of any intra-articular treatment, glucosamine sulphate, chondroitin sulphate and/or diacerein within the 3 months prior to their inclusion in the study.
    Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy.
    Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
    Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral or fungal infections.
    Clinical diagnosis established of uncontrolled diabetes mellitus, with fasting glucose greater than 126 mg.
    Patients with asthma.
    Any pathology that could interfere with the administration or assessment.
    History of hypersensitivity to any excipients or pharmacological product.
    Patients awaiting surgery.
    Patients awaiting disablement assessment.
    Previous participation in this protocol.
    Sobrepeso (Índice de Masa Corporal mayor o igual a 35).
    Embarazo o lactancia. Mujeres en edad fértil que no utilicen anticonceptivos eficaces.
    Enfermedad patelofemoral predominante.
    Pacientes con trauma clínicamente relevante o cirugía en la rodilla seleccionada.
    Administración de AINEs durante los 14 días previos a la inclusión en el estudio.
    Administración de cualquier tratamiento intraarticular glucosamina sulfato, condroitín sulfato y/o diacereína durante los 3 meses previos a la inclusión en el estudio.
    Enfermedades reumáticas recurrentes (antecedentes y/o signos actuales) que pudieran confundir o interferir con la evaluación de eficacia en el dolor.
    Dolor localizado en una parte del cuerpo diferente de la rodilla seleccionada que pudiera interferir con la evaluación.
    Sujetos con infección aguda o crónica activa que requieran tratamiento antibiótico, o enfermedad vírica severa o infecciones fúngicas.
    Diagnóstico clínico de diabetes mielitus no controlada, con valores de glucosa en ayunas mayores de 126 mg.
    Pacientes con asma.
    Cualquier patología que pudiera interferir con el desarrollo del estudio o la valoración.
    Pacientes con sensibilidad o intolerancia a los fármacos en estudio o cualquiera de sus excipientes.
    Pacientes en lista de espera para cirugía.
    Pacientes en situación de demanda por incapacidad.
    Participación previa en este protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of pain in Visual Analogue Scale (0-100 mm) at the end of treatment. Success will be considered as an absolute difference of 10 points at the end of treatment between chondroitin sulfate+glucosamine sulfate group and placebo group.
    Reducción del dolor en la Escala Visual Analógica (0-100 mm) al final del tratamiento. Se considerará como éxito una diferencia absoluta de 10 puntos al final del tratamiento entre el grupo de condroitín sulfato+glucosamina sulfato y el grupo placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months (end of treatment period).
    6 meses (final del periodo de tratamiento).
    E.5.2Secondary end point(s)
    OMERACT-OARSI responder criteria (and corresponding subscales), WOMAC score with the use of 0-100 mm VAS, Global Investigator Assessment and the consumption of rescue medication.
    Criterios de respuesta OMERACT-OARSI (y sus correspondientes subescalas), puntuación del índice WOMAC mediante el uso de la EVA 0-100 mm, Valoración Global del Investigador y consumo de medicación de rescate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 6 months during treatment.
    1, 3 y 6 meses durante el tratamiento.
    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 Yes
    E.8.1.7.1Other trial design description
    Prospectivo, multicéntrico.
    Prospective, multicentre.
    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 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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    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 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: 314
    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 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 state314
    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)
    It is not different from the expected normal treatment of that pathologie.
    No es diferente del tratamiento normal esperado de esta patología.
    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 Decision2013-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
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