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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2008-003375-41
    Sponsor's Protocol Code Number:KETOP_L_03948
    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:2008-07-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-003375-41
    A.3Full title of the trial
    Etude de non-infériorité Bi-Profénid® 200 mg versus Bi-Profénid® 300 mg chez des patients présentant des douleurs liées à des affections aiguës bénignes fermées post-traumatiques de l'appareil locomoteur ou rhumatologiques aiguës non infectieuses.
    A.3.2Name or abbreviated title of the trial where available
    BIPROPAIN
    A.4.1Sponsor's protocol code numberKETOP_L_03948
    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 Sponsorsanofi-aventis France
    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 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 nameBi-Profenid 100 mg
    D.3.2Product code KETOP
    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 INNkétoprofène
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 BI-PROFENID 150 mg comprimé sécable
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis France
    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.3.4Pharmaceutical 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 INNkétoprofène
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    douleurs liées à des affections aiguës bénignes fermées post-traumatiques de l’appareil locomoteur ou rhumatologiques aiguës non infectieuses
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10065016
    E.1.2Term Post-traumatic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de cette étude est de démontrer la non-infériorité de Bi-Profénid® 100 mg × 2 /jour versus Bi-Profénid® 150 mg × 2 /jour chez des patients présentant des douleurs liées à des affections aiguës bénignes fermées post-traumatiques de l’appareil locomoteur ou rhumatologiques aiguës non infectieuses, en comparant d’une part l’évolution de l’intensité de la douleur au repos, sur l’ensemble de la journée, mesurée en fin de journée à partir d’une échelle numérique (EN), sur 5 jours et d’autre part, la consommation totale sur 5 jours des antalgiques associés.
    E.2.2Secondary objectives of the trial
    Les objectifs secondaires de cette étude sont :
    • Décrire les traitements antalgiques associés
    • Décrire le délai entre l’inclusion du patient et le premier recours à un antalgique de palier I, II ou III
    • Evaluer le soulagement des patients à partir d’une échelle de Likert en 4 classes à 5 jours (soulagement total ou important ; soulagement modéré ; soulagement léger et absence de soulagement)
    • Evaluer l’évolution de l’intensité de la douleur en mouvement, sur l’ensemble de la journée, mesurée en fin de journée à partir d’une EN sur 5 jours
    • Evaluer la satisfaction globale du patient en fin de traitement à partir d’une Echelle Verbale Simple (EVS) à 4 points (très satisfait, plutôt satisfait, plutôt insatisfait, très insatisfait)
    • Evaluer la satisfaction globale de l’investigateur en fin d’étude à partir d’une Echelle Verbale Simple (EVS) à 4 points (très satisfait, plutôt satisfait, plutôt insatisfait, très insatisfait)
    • Comparer la tolérance des deux traitements
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Homme ou femme, âgé(e) de plus de 18 ans et de moins de 65 ans

    • Femmes utilisant un moyen contraceptif et ayant un test de grossesse urinaire négatif avant l’entrée dans l’étude ou femmes ménopausées depuis > 1an

    • Patient présentant un des critères suivants :

     Traumatisme bénin fermé de l’appareil locomoteur survenu dans les 24 heures,

     Contusion de l’appareil locomoteur survenue dans les 24 heures,


     Affections rhumatologiques aiguës (lombalgie aiguë, lombosciatique et névralgie cervico-brachiale)

     Rhumatismes abarticulaires

    • Nécessitant un traitement par Bi-Profénid® pendant 5 jours

    • Ayant une intensité de la douleur au repos mesurée à partir d’une échelle numérique, au moment de l’inclusion ≥ 3 (avant tout début de traitement)

    • Affilié à un régime de sécurité sociale ou bénéficiaire d’un tel régime

    • Bénéficiant d’un examen clinique préalable adapté à l’étude
    E.4Principal exclusion criteria
    Liés au patient :

    • Impossibilité de donner son consentement
    • Impossibilité de compléter le carnet d’auto-évaluation pendant 5 jours
    • Impossibilité de revenir en consultation à 8 (±2) jours

    Liés à l’étude :

    • Nécessité d’une chirurgie
    • Nécessité d’hospitalisation
    • Nécessité d’un antalgique autre que palier I à la visite d’inclusion
    • Nécessité d’un traitement par un autre AINS sélectif ou non (per os et/ou topiques) y compris aspirine, inhibiteurs sélectifs de la cyclo-oxygénase 2, corticoïdes ou myorelaxant à l’inclusion et pendant la durée de l’étude
    • Traumatisme grave : luxation du genou, toutes les fractures, rupture du type tendon d’Achille
    • Entorse plâtrée
    • Bursite
    • Syndrome infectieux local et/ou général sévère

    Liés aux produits à l’étude :

    • Hypersensibilité au kétoprofène ou à l'un des excipients du produit
    • Antécédent d'asthme déclenché par la prise de kétoprofène ou de substances d'activité proche telles qu’autres AINS, aspirine
    • Hémorragie gastro-intestinale, hémorragie cérébro-vasculaire ou autre hémorragie en évolution
    • Antécédents d’hémorragie ou de perforation digestive au cours d’un précédent traitement par AINS
    • Ulcère intestinal en évolution
    • Ulcère peptique évolutif, antécédents d’ulcère peptique ou d’hémorragie récurrente (2 épisodes distincts ou plus d’hémorragie ou d’ulcérations objectivés)
    • Insuffisance hépatique sévère
    • Insuffisance rénale sévère
    • Insuffisance cardiaque sévère
    • Hypertension artérielle non contrôlée
    • Hypersensibilité ou intolérance au gluten, en raison de la présence d'amidon de blé (gluten)
    • Patients traités par un des traitements suivants :
     Anticoagulants (oraux, héparines)
     Antiagrégants plaquettaires
     Inhibiteurs sélectifs de la recapture de la sérotonine
     Lithium
     Méthotrexate
     Pemetrexed
     Immunosuppresseurs.
    E.5 End points
    E.5.1Primary end point(s)
    Les co-critères principaux de l’étude seront l’évaluation entre J1 et J5 de l’intensité de la douleur au repos sur l’ensemble de la journée, mesurée en fin de journée à partir d’une échelle numérique et la consommation totale sur 5 jours des antalgiques associés.
    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 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
    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 months
    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 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) 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 state362
    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 Decision2008-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-16
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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
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