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    Summary
    EudraCT Number:2011-005398-22
    Sponsor's Protocol Code Number:ARACONDRO-001
    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:2012-01-11
    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 number2011-005398-22
    A.3Full title of the trial
    A randomized, multicenter, double-blind, double dummy and parallel study to evaluate the efficacy of the combination of Chondroitin sulfate and Glucosamine hydrochloride in a single dose chewable tablet versus Placebo, using Celecoxib as an active control in patients with knee osteoarthritis with moderate to severe pain.
    Ensayo clínico aleatorizado, multicéntrico, de doble ciego, en paralelo y doble simulación para la evaluación de la eficacia de la combinación de Condroitín sulfato y clorhidrato de Glucosamina, en un comprimido masticable de dosis única, versus Placebo, utilizando Celecoxib como control activo, en pacientes con Artrosis de rodilla con dolor moderado-grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing a new signle dose chewable tablet as treatment knee osteoarthritis with moderate to severe pain, compared to Placebo and Celecoxib
    A.3.2Name or abbreviated title of the trial where available
    ARACONDRO
    A.4.1Sponsor's protocol code numberARACONDRO-001
    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 SponsorARAFARMA GROUP, 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 supportARAFARMA GROUP, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRecerca Clinica SL
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressC/ Pamplona 92-94
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08018
    B.5.3.4CountrySpain
    B.5.4Telephone number34933005218
    B.5.5Fax number34934851401
    B.5.6E-mailcod@recercaclinica.es
    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 nameARACONDRO
    D.3.4Pharmaceutical form Chewable 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.3.9.1CAS number 9007-28-7
    D.3.9.3Other descriptive nameCHONDROITIN SULFATE
    D.3.9.4EV Substance CodeSUB13355MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 66-84-2
    D.3.9.3Other descriptive nameGLUCOSAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02354MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 placeboChewable 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
    Knee osteoarthritis with moderate to severe pain.
    Pacientes afectos de artrosis de rodilla que presenten un dolor moderado a grave.
    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 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effectiveness of combination of chondroitin sulphate and Glucosamine hydrochloride in a single chewable tablet versus
    placebo in the symptomatic treatment of knee osteoarthritis,
    in patients with moderate to severe pain, using Celecoxib
    effectiveness as a positive control.
    Evaluar la efectividad de la combinación de sulfato de condroitina y glucosamina clorhidrato en una sola tableta para chupar contra
    placebo en el tratamiento sintomático de la artrosis de rodilla,
    en pacientes con dolor moderado a severo, con Celecoxib
    eficacia como control positivo.
    E.2.2Secondary objectives of the trial
    Assessment of the improvement in pain and functionality of knee, using the sub-scales of the WOMAC questionnaire, safety of treatment, use of rescue medication, patient Quality of Life, responders according to
    OMERACT-OARSI criteria 2004.
    El presente estudio pretende evaluar de la mejoría en el dolor y la funcionalidad de la rodilla, con las sub-escalas del cuestionario WOMAC, la seguridad del tratamiento, el uso de medicación de rescate, la calidad de vida del paciente, que responden de acuerdo a
    OMERACT-OARSI criterios de 2004.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Osteoarthritis of the knee diagnosed by the diagnostic criteria of the ACR.
    2. Pain with moderate to severe score between 301 and 400 in the WOMAC subscale pain, or well with a score greater than 4 cm visual analogue scale of 10 cm.
    3. Diagnosis clinical pain and functional limitation in the 6 months prior to the inclusion.
    4. Male or Felame patients, aged over 40 years.
    5. Ability and commitment to compliance with study procedures and
    scheduling follow-up visits.
    6. Intellectual Ability to understand and sign the Informed Consent document.
    1. Artrosis de rodilla diagnosticada según los criterios de diagnóstico de la ACR.
    2. Dolor moderado-grave con puntuación entre 301 y 400 en la sub-escala WOMAC de dolor, o bien con una puntuación mayor de 4 cm en escala visual analógica de 10 cm.
    3. Diagnóstico clínico de dolor y limitación funcional, durante los 6 meses anteriores a la consulta.
    4. Ambos sexos, con una edad mayor de 40 años.
    5. Capacidad y compromiso en el cumplimiento de los procedimientos de estudio y programación de las visitas de seguimiento.
    6. Capacidad intelectual para comprender y firmar el documento de Consentimiento Informado.
    E.4Principal exclusion criteria
    1. Allergy to shellfish or any component of the study medication.
    2. Known hypersensitivity to the active substance or any excipients of Celecoxib.
    3. Cardiovascular disease incompatible with the use of Celecoxib.
    4. Joint or bone disease known as chondrocalcinosis, Paget's disease, arthritis rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis or Wilson's disease.
    5. History or presence of active rheumatic disease that could be responsible for a secondary osteoarthritis.
    6. Severe swelling of the joint confirmed by physical examination, speed
    ESR> 40 mm / h and positive rheumatoid factor.
    7. Index of body mass index (BMI) greater than 30 kg/m2.
    8. Hematologic or metabolic, liver or kidney abnormalities at the discretion of Investigator, may hinder a patient's serious commitment to adhere to treatment during the study period.
    9. Administration intra-articular or systemic corticosteroids in the last 3 months.
    10. Previous use of SYSADOAs in the last 6 months.
    11. History of significant trauma or surgery on the affected joint.
    12. Arthroplasty of the affected joint arthroplasty or programming in the next 6 months.
    13. Use of narcotic analgesics.
    14. Known hypersensitivity to sulphonamide and paracetamol.
    15. Active peptic ulceration or gastrointestinal bleeding.
    16. Patients who have experienced asthma, acute rhinitis, nasal polyps, edema urticaria or other allergic-type reactions after taking aspirin
    aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs), including
    COX-2.
    17.Inflammatory Bowel Disease.
    18 Estimated creatinine clearance of <30 ml / min
    19 Serum albumin <25 g / L
    20. Any circumstance which, at the discretion of the investigator, would prevent the patient to follow rigorously the the study protocol.
    21. Women of childbearing potential not using a reliable method of birth control.
    22. Women who are pregnant or nursing mothers.
    23. Patients who are using other investigational agent for the treatment trial.
    24. Patients who are in the process of litigation to get the disability or incapacity.
    1. Alergia al marisco o cualquiera de los componentes del tratamiento en estudio.
    2. Antecedentes de hipersensibilidad al principio activo o cualquiera de los excipientes de Celecoxib.
    3. Cardiopatía incompatible con el uso de Celecoxib.
    4. Enfermedad ósea o articular conocida como condrocalcinosis, enfermedad de Paget, artritis reumatoide, artritis psoriásica, acromegalia, hemocromatosis, enfermedad de Wilson.
    5. Historia o presencia de enfermedad reumática activa que pudiera ser responsable de una artrosis secundaria.
    6. Inflamación grave de la articulación confirmada por exploración física, velocidad de sedimentación globular > 40 mm/h y factor reumatoide positivo.
    7. Índice de masa corporal (IMC) mayor de 30 Kg/m2.
    8. Anormalidades hematológicas o metabólicas, hepáticas o renales que, a criterio del investigador, podrían dificultar un serio compromiso del paciente en adherirse al tratamiento durante la duración del estudio.
    9. Administración sistémica o intra-articular de corticosteroides en los últimos 3 meses.
    10. Utilización previa de SYSADOAs en los últimos 6 meses.
    11. Historia de traumatismo significativo o de cirugía en la articulación afectada.
    12. Artroplastia de la articulación en estudio o programación de artroplastia en los próximos 6 meses.
    13. Uso de analgésicos narcóticos.
    14. Hipersensibilidad conocida a las sulfamidas y paracetamol.
    15. Ulceración péptica activa o hemorragia gastrointestinal.
    16. Pacientes que hayan experimentado asma, rinitis aguda, pólipos nasales, edema angioneurótico, urticaria u otras reacciones de tipo alérgico después de tomar ácido acetilsalicílico u otros fármacos antiinflamatorios no esteroideos (AINE), incluyendo
    inhibidores de la COX-2.
    17. Enfermedad inflamatoria intestinal.
    18. Aclaramiento de creatinina estimado < 30 ml/min
    19. Albúmina sérica < 25 g/L
    20. Cualquier circunstancia que, a criterio del investigador, impida al paciente seguir con rigor el protocolo del estudio.
    21. Mujeres en edad fértil que no utilicen un método fiable de control de natalidad.
    22. Mujeres embarazadas o en estado de lactancia.
    23. Pacientes que estén utilizando otro agente en investigación durante el tratamiento de ensayo.
    24. Pacientes que se encuentren en proceso de litigio para obtener la invalidez o incapacidad.
    E.5 End points
    E.5.1Primary end point(s)
    Decrease of 26% in the total score of the questionnaire WOMAC score at 6 months of treatment with initial baseline.
    Disminución de 26% en la puntuación total de la puntuación WOMAC cuestionario a los 6 meses de tratamiento con base inicial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Decrease of questionnaire WOMAC score at 6 months of treatment (End of Study).
    Disminución del cuestionario WOMAC a los 6 meses de tratamiento (final del estudio).
    E.5.2Secondary end point(s)
    1. Improvement in pain in the WOMAC subscale.
    2. Improvement in stiffness in the WOMAC subscale.
    3. Improvement in the function in the WOMAC subscale.
    4. Evaluation of the safety of each treatment group.
    5. Assessment by the patient global evolution of osteoarthritis.
    6. Use of rescue medication.
    7. Use of other concomitant medications: gastroprotective, anxiety and / or antidepressants.
    8. Presence of swelling or effusion, or both.
    9. Quality of life according to the HAQ form.
    10. Valuation global medical
    11. Responder Patients according to OMERACT-OARSI criteria 2004.
    1. Variación en la puntuación total del cuestionario WOMAC.
    2. Mejora en la rigidez en la sub-escala WOMAC.
    3. Mejora en la función en la sub-escala WOMAC.
    4. Evaluación de la seguridad de cada grupo de tratamiento.
    5. Valoración global por el paciente de la evolución de su artrosis.
    6. Uso de medicación de rescate.
    7. Uso de otra medicación concomitante: protectores gástricos, ansiolíticos y/o antidepresivos.
    8. Presencia de inflamación o derrame, o ambos.
    9. Calidad de vida según el formulario HAQ.
    10. Valoración médica global mediante escala CGI.
    11. Pacientes respondedores según criterios OMERACT-OARSI de 2004.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 1 to 5 and from 9 to 11: End of Study.

    From 6 to 8: During the course of the study.
    Desde 1 a 5 y desde 9 a 11: Final del estudio

    Desde 6 a 8: Durante el transcurso del estudio.
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned40
    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
    Last Visit of Last Patient
    La última visita del último paciente.
    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 months6
    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 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 251
    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 state501
    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)
    ARACONDRO responders may continue with the drug administration or an alternative therapy at their physician's discretion.

    Placebo and Control group patients who complete the study will receive a therapy at their
    physician's discretion.

    Control group patients who fail to meet the primary endpoint and/or who early terminated their particiaption any time will be regarded as a treatment failure. They may switch to a new therapy at their physician's discretion.
    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 Decision2012-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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