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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2010-022625-15
    Sponsor's Protocol Code Number:2010-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-022625-15
    A.3Full title of the trial
    Evaluation de l’efficacité de l’association ibuprofène et codéine versus l’ibuprofène seul dans le traitement de la poussée douloureuse de la gonarthrose. Etude en double aveugle, randomisée contrôlée de 2 groupes parallèles de patients traités pendant 7 jours.
    A.3.2Name or abbreviated title of the trial where available
    EVACOD
    A.4.1Sponsor's protocol code number2010-01
    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 SponsorLaboratoires ELERTE
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name ANTARENE CODEINE
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires ELERTE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAntarene codeine
    D.3.4Pharmaceutical form 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 INNIbuprofene
    D.3.9.1CAS number 15687-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCodeine
    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) 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.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 Yes
    D.2.1.1.1Trade name ANTARENE
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires ELERTE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAntarene 400
    D.3.4Pharmaceutical form 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 INNIbuprofene
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Gonarthrose fémoro-tibiale uni ou bilatérale en poussée douloureuse
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer la supériorité de l’efficacité de l’ibuprofène codéine (Antarène® Codéine) par rapport a l’ibuprofène seul (Antarène®) dans le traitement de la poussée aiguë de gonarthrose à 4 jours.
    E.2.2Secondary objectives of the trial
    Comparer l’efficacité de l’ibuprofène codéine (Antarène® Codéine) par rapport a l’ibuprofène seul (Antarène ®) dans le traitement de la poussée aiguë de gonarthrose à 7 jours.

    Comparer la qualité de vie à 7 jours évaluée par le questionnaire SF-12.

    Comparer la tolérance des deux produits à 4 jours et à 7 jours.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient homme ou femme âgé de 40 à 80 ans.
    Patient atteint de gonarthrose fémoro-tibiale primitive répondant aux critères de l’ACR :
    Douleur mécanique du genou et au moins un des 3 critères suivants :
    1. Age ≥ 50 ans
    2. Raideur matinale < 30 minutes
    3. Craquements du genou aux mouvements actifs
    et Ostéophytes sur la radiographie des deux genoux de face.
    Patient dont l’arthrose a été définie radiologiquement: pincement de l’interligne articulaire et ostéophyte sur des clichés datant de moins d’un an et stade Ib à III de KELLGREN/LAWRENCE modifié (c'est-à-dire pincement de l’interligne articulaire compris entre 25% et 75% et ostéophyte certain).
    Patient symptomatique, d’un seul coté, avec un score d’échelle de la douleur EVA ≥50 mm, ou bien si gonarthrose bilatérale évaluation sur le coté le plus douloureux.
    Patient avec douleur présente au moins quinze jours dans le mois précédent l’inclusion.
    Patient ne prenant aucun antalgique et aucun AINS depuis au moins 2 jours à 5 jours selon l’AINS
    Patient n’ayant pas pris de paracétamol depuis au moins 12 heures
    Patient ne nécessitant pas une ponction pour hydarthrose.
    Patient assuré social.
    Patient apte à comprendre et à suivre les instructions de l’étude.
    Patient ayant signé un consentement éclairé

    E.4Principal exclusion criteria
    Patient ayant une gonarthrose non ou insuffisamment symptomatique.
    Gonarthrose secondaire post traumatique.
    Gonarthrose de stade radiologique Ia ou IV.
    Patient atteint de coxarthrose homolatérale symptomatique.
    Déformation en varus ou valgus du genou à tester (axe de déformation ≥ 15° sur les radiographies).
    Hydarthrose très importante (à ponctionner) au moment de l’inclusion.
    Patient atteint d’un rhumatisme inflammatoire (PR, rhumatisme psoriasique, chondrocalcinose articulaire, goutte, maladie de Paget, spondylarthrite ankylosante, lupus, etc.).
    Antécédent de traumatisme sur le genou gonarthrosique dans les six mois précédant l’inclusion.
    Radiculalgie crurale ou sciatique du membre inférieur.
    Tendinopathie (périarthrite de hanche).
    Sujet ayant reçu une injection de corticostéroïde intra-articulaire dans le genou sélectionné dans les 2 mois précédant l’inclusion.
    Sujet recevant un traitement par AASAL depuis moins de 3 mois lors de l’inclusion ou dont le traitement n’est pas stable pendant les 3 mois précédant l’inclusion.
    Traitement anticoagulant par héparine, warfarine ou analgésique en cours (les anti agrégants plaquettaires tels que aspirine ≤ 325 mg/j, Ticlopidine (TICLID®) ou, le Clopidogrel (PLAVIX®) sont possibles.
    Mise en place d’une prothèse totale dans le genou à tester.
    Patient ayant une affection sévère susceptible d’interférer avec l’évaluation, telle que : néoplasie, hémopathie maligne, néphropathie, hépatopathie ou infection sévère.
    Sujet participant à un autre essai.
    Femme enceinte, ou susceptible de le devenir pendant l’essai, ou allaitante.
    Patient présentant une intolérance à l’ibuprofène ou à la codéine
    Patient présentant une contre indication aux AINS :
    - Antécédents d'allergie ou d'asthme déclenchés par la prise d'ibuprofène ou de substances d'activité proche telles que les autres AINS, aspirine.
    - Antécédents d'allergie aux autres constituants du comprimé d’Antarène®.
    - Ulcère gastroduodénal en évolution.
    - Insuffisance hépatocellulaire sévère.
    - Insuffisance rénale sévère.
    - Insuffisance cardiaque sévère non contrôlée.
    - Lupus érythémateux disséminé.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacité :
    Les critères principaux à J4 sont : La réduction de l’intensité de la douleur évaluée par une échelle visuelle analogique.


    Tolérance :
    La tolérance locale et globale évaluée par le patient et l’investigateur.
    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 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 No
    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.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Dernière visite dernier patient
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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) Yes
    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 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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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 Decision2010-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-19
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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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