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    The EU Clinical Trials Register currently displays   35543   clinical trials with a EudraCT protocol, of which   5841   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006015-57
    Sponsor's Protocol Code Number:RBHP2011PICKERING5
    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:2012-01-23
    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 number2011-006015-57
    A.3Full title of the trial
    ETUDE CLINIQUE COMPARANT L’EFFICACITE DU PARACETAMOL PERMUQUEUX BUCCAL 125 MG VERSUS CELLE DU PARACETAMOL INJECTABLE 1 G, EN PERFUSION LENTE IV CHEZ DES PATIENTS SOUFFRANT DE DOULEUR AIGUË.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ETUDE CLINIQUE COMPARANT L’EFFICACITE DU PARACETAMOL PERMUQUEUX BUCCAL 125 MG VERSUS CELLE DU PARACETAMOL INJECTABLE 1 G, EN PERFUSION LENTE IV CHEZ DES PATIENTS SOUFFRANT DE DOULEUR AIGUË.
    A.3.2Name or abbreviated title of the trial where available
    ParaJug
    A.4.1Sponsor's protocol code numberRBHP2011PICKERING5
    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 SponsorCHU de Clermont-Ferrand
    B.1.3.4CountryFrance
    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 supportUnither Pharmaceuticals
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Clermont-Ferrand
    B.5.2Functional name of contact pointLACARIN
    B.5.3 Address:
    B.5.3.1Street Address58, rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473751195
    B.5.5Fax number0033473754730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    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 nameParacetamol permuqueux buccal
    D.3.2Product code Paracetamol permuqueux buccal
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARACETAMOL
    D.3.9.1CAS number 103-90-2
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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) 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.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 Paracétamol injectable
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA
    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 nameParacétamol
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARACETAMOL
    D.3.9.1CAS number 103-90-2
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 placeboOral solution
    D.8.4Route of administration of the placeboBuccal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Traumatologie des membres supérieurs ou inférieurs (entorses, contusions musculaires , …) associée à une douleur aiguë d’intensité modérée (EVN entre 4 et 6)
    E.1.1.1Medical condition in easily understood language
    Douleur aigüe suite à traumatisme
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066714
    E.1.2Term Acute pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation chez des patients présentant une douleur aiguë d’intensité modérée l’efficacité du paracétamol permuqueux buccal administré par voie gingivo-jugale comparé au paracétamol administré par voie intraveineuse en évaluant la variation de la cotation de douleur évaluée par échelle visuelle numérique entre T0 et T0+30 minutes.
    E.2.2Secondary objectives of the trial
    -Evaluation chez des patients présentant une douleur aiguë d’intensité modérée l’efficacité du paracétamol permuqueux buccal administré par voie gingivo-jugale comparé au paracétamol administré par voie intraveineuse en évaluant la variation de la cotation de douleur évaluée par échelle visuelle numérique entre T0 et T0+240 minutes en calculant l’aire sous la courbe (AUC),

    -Evaluation chez des patients présentant une douleur aiguë d’intensité modérée l’efficacité du paracétamol permuqueux buccal administré par voie gingivo-jugale comparé au paracétamol administré par voie intraveineuse en évaluant la variation de la cotation de douleur évaluée par échelle visuelle numérique entre T0 et TEVmax en calculant l’aire sous la courbe (AUC),

    -Evaluation de l’acceptabilité et de la tolérance du produit permuqueux administré.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient admis aux urgences du CHU de Clermont-Ferrand pour traumatologie des membres supérieurs ou inférieurs (entorses, contusions musculaires , …) associée à une douleur aiguë d’intensité modérée (EVN entre 4 et 6) jugée par l’investigateur comme nécessitant une perfusion de paracétamol IV 1g,
    - Patient indemne de tout traitement chronique jugé par l’investigateur ou son représentant comme étant non compatibles avec l’essai,
    - Patient âgé de 18 à 60 ans,
    - Sexe masculin ou féminin,
    - Coopération et compréhension suffisantes pour se conformer aux impératifs de l’étude,
    - Acceptation de donner un consentement écrit,
    - Affiliation au régime de la Sécurité Sociale française.
    E.4Principal exclusion criteria
    - Contre-indications à l’administration de paracétamol :
    - Hypersensibilité connue au paracétamol
    - Antécédents d’hépatite B ou C
    - Insuffisance rénale sévère
    - Insuffisance hépatocellulaire,
    - Antécédents médicaux et/ou chirurgicaux jugés par l’investigateur ou son représentant comme étant non compatibles avec l’essai,
    - Pathologie évolutive au moment du bilan d’inclusion,
    - Suspicion d’un état alcoolique du patient ou toxicomanie à l’admission,
    - Patient présentant toute inflammation ou pathologie ulcérative de la muqueuse buccale (aphtes...),
    - Patient traité par antalgique(s) ou anti-inflammatoires(s) dans les 6 dernières heures,
    - Patient refusant d’ingérer de l’alcool pour raisons personnelles,
    - Femme en âge de procréer sans moyen contraceptif efficace,
    - Femme enceinte ou allaitante,
    - Patient participant à un autre essai ou se trouvant dans une période d’exclusion,
    - Patient avec coopération et compréhension ne permettant pas de se conformer de façon stricte aux conditions et procédures prévues par le protocole,
    - Patient bénéficiant d’une mesure de protection légale (curatelle, tutelle…).
    E.5 End points
    E.5.1Primary end point(s)
    Cotation de douleur mesurée par échelle visuelle numérique
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0 et T0+30 minutes.
    E.5.2Secondary end point(s)
    - Cotation de douleur mesurée par échelle visuelle numérique à T0, T0+5min, T0+10min, T0+15min, T0+20min, T0+40min, T0+60min, T0+90min, T0+120 minutes, T0+180 minutes et T0+240 minutes,
    - Cotation de douleur mesurée par échelle visuelle numérique à T0 et TEVmax,
    - Evaluation de l’acceptabilité du produit permuqueux par le remplissage d’un questionnaire d’appréciation par le patient,
    - Evaluation du profil de tolérance par recueil des événements indésirables graves et non-graves.
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0, T0+5min, T0+10min, T0+15min, T0+20min, T0+40min, T0+60min, T0+90min, T0+120 minutes, T0+180 minutes et T0+240 minutes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial2
    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 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
    Fin de l'essai = dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    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: 44
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state44
    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)
    La prise en charge de la pathologie considérée dans l'essai n'est pas modifiée.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation CHU de Clermont-Ferrand
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
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