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    Summary
    EudraCT Number:2015-002485-24
    Sponsor's Protocol Code Number:CHUBX2014/09
    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:2015-06-24
    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 number2015-002485-24
    A.3Full title of the trial
    Effectiveness of oral prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a non inferiority randomized clinical trial.
    Essai randomisé de non infériorité sur l’efficacité de la prednisolone par voie orale par rapport au traitement endodontique partielle sur la réduction de la douleur dans les soins d'urgence de pulpite irréversible aiguë de molaires mandibulaires.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of oral prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a non inferiority randomized clinical trial.
    Essai randomisé de non infériorité sur l’efficacité de la prednisolone par voie orale par rapport au traitement endodontique partielle sur la réduction de la douleur dans les soins d'urgence de pulpite irréversible aiguë de molaires mandibulaires.
    A.3.2Name or abbreviated title of the trial where available
    PULPISOLONE
    A.4.1Sponsor's protocol code numberCHUBX2014/09
    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 Bordeaux
    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 supportCHU de Bordeaux
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointREC
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557820475
    B.5.5Fax number33556794926
    B.5.6E-mailsebastien.marchi@chu-bordeaux.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 Yes
    D.2.1.1.1Trade name Solupred 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANOF-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 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 INNPREDNISOLONE METASULFOBENZOATE SODIUM
    D.3.9.1CAS number 630-67-1
    D.3.9.4EV Substance CodeSUB20372
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Solupred 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANOF-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 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 INNPREDNISOLONE METASULFOBENZOATE SODIUM
    D.3.9.1CAS number 630-67-1
    D.3.9.4EV Substance CodeSUB20372
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulpitis
    Pulpite
    E.1.1.1Medical condition in easily understood language
    Pulpitis
    Pulpite
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to compare the effect of short-course oral corticotherapy versus partial endodontic treatment for the emergency care of the irreversible pulpitis in mandibulary molars on pain 24 hours after the emergency visit.
    L’objectif principal est de comparer l’intensité de la douleur selon la stratégie de prise en charge de la pulpite irréversible mandibulaire : corticothérapie de courte durée per-os versus traitement endodontique partiel, 24 heures après la consultation d’urgence.
    E.2.2Secondary objectives of the trial
    Global assessment of care conditions using several tools:
    - Number of analgesic drug step 1 on the World Health Organization analgesic ladder or step 2 taken after the inclusion visit and over 72 hours
    - Difference in pain measured by numeric scale (NS) between the emergency visit and 24 after
    - Kinetics of the pain self-assessed by NS at 6, 12, 24, 48 and 72 hours after the emergency visit
    - Number of injected anesthetic cartridges for clinical silence for the realization of the complete endodontic treatment
    - Number of patients back for the complete endodontic treatment.
    - Patient’s comfort during the endodontic treatment measured by the scale "Iowa Satisfaction with Anesthesia Scale" (ISAS)
    Les objectifs secondaires sont d’évaluer globalement les conditions de déroulement des soins par des outils de mesures objectifs et subjectifs :
    - La prise d’antalgiques de palier 1 (Paracétamol 1g) ou de palier 2 (Paracétamol 600 mg / Codéine 50mg) après consultation initiale, et ce jusqu’à 72h, notés en date et en heure sur le cahier de suivi.
    - La douleur selon les deux groupes par étude de la différence de douleur mesurée par EN entre H-0 (inclusion) et H-24.
    - La cinétique de résolution de la douleur par EN auto-évalué à 6 heures puis à 12h, 24h, 48h et 72 heures après la consultation/intervention d’urgence
    - Le nombre de patients revenus à la consultation à 72h pour le traitement endodontique.
    - Le nombre de cartouches d’anesthésie injectées pour obtenir un silence clinique lors de la réalisation du traitement endodontique.
    - Le confort de la prise en charge pendant le traitement endodontique, mesuré par l’échelle « Iowa Satisfaction with Anesthesia Scale » (ISAS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants will be included if they meet the following inclusion criteria:
    - clinical signs of irreversible pulpitis on a mandibular molar,
    - ASA1 or ASA2 score (American Society of Anesthesiologists)
    - Age between 18 and 70 years (of either gender)
    - Ability to give written informed consent
    - Affiliation to a health insurance scheme
    - Agreement to be contacted by phone 24h after the emergency visit
    - Availability to come back 72 hours after the emergency visit for complete endodontic treatment
    • Patients consultant en urgence au service d’Odontologie et de santé buccale du CHU de Bordeaux
    • Présentant des signes cliniques de pulpite irréversible aigüe sur une molaire mandibulaire
    • Patient présentant un score ASA (American Society of Anesthesiologist) 1 et 2
    • Majeur (<70 ans) et responsable
    • Affilié ou bénéficiaire d'un régime de Sécurité Sociale
    • Ayant une assurance santé complémentaire
    • Acceptant de participer à l’étude
    • Disponible pour un rendez-vous 72 h après la consultation initiale pour le traitement endodontique.
    • Acceptant de répondre par téléphone 24H après la visite d’inclusion
    • Parlant le français, sachant le lire et l’écrire.
    E.4Principal exclusion criteria
    Participants will be excluded if they present at least one of the following exclusion criteria:
    - diagnosis of reversible pulpitis , acute apical periodontitis, periodontal lesion of endodontic origin or dentin syndrome
    - not retainable tooth requiring extraction
    - contraindication of endodontic treatment (endocarditis risk),
    - contraindication for the prescription of glucocorticoids or codeine,
    - viral disease in evolution (hepatitis, herpes zoster, .. ),
    - machine operators ,
    - psychosis uncontrolled by treatment,
    - allergy to one or more of the components,
    - diabetes, drug intake with direct interaction with glucocorticoids or codeine,
    - woman of child-bearing age without contraceptive, pregnancy, breastfeeding
    - not able to give informed consent,
    - participating in another interventional study.
    • Pulpite réversible, Parodontite Apicale Aigue (P.A.A), Lésion Péri-Radiculaire d'Origine Endodontique (L.I.P.O.E), Syndrome dentinaire, Pulpite Réversible (lors de l'examen clinique initial)
    • Refus de la participation à l'étude ou non coopération.
    • Dent non conservable nécessitant une avulsion.
    • Signe clinique de nécrose ou de signe radiologique d'infection de la dent causale (lors de l’examen radiologique).
    • Présence de foyers infectieux dentaires, maladie virale en évolution (hépatite, herpès, zona,..),
    • Troubles trophiques ou terrain muqueux incompatible avec le conditionnement oro-dispersible du comprimé de Prednisolone.
    • Les contre-indications (allergies, interactions,..) absolues et relatives aux glucocorticoïdes de synthèse sont les suivantes : infections systémiques, hépatite aigue, herpes, zona, glaucome, allergies à un ou plusieurs des composants ou excipients, cirrhose alcoolique, colique ulcérative, diabète de type I, immunodépression (VIH, Chimiothérapie,..), comportement psychotique non contrôlé et allaitement. Le risque d’interaction médicamenteuse potentielle doit être pris en compte par le clinicien pour la décision de mise sous traitement.
    • La contre-indication à l’anesthésie locale est l’hypersensibilité à l’un des constituants du produit.
    • Les contre-indications au paracétamol / codéine sont : hypersensibilité au paracétamol, insuffisance hépato-cellulaire, porphyrie, phénylcétonurie, asthme et insuffisance respiratoire, allaitement, association aux agonistes-antagonistes morphiniques : buprénorphine, nalbuphine, pentazocine, En raison de la présence de sorbitol, ce médicament est contre-indiqué en cas d'intolérance au fructose.
    • La contre-indication au traitement endodontique en plusieurs séances : cardiopathie à risque d’endocardite infectieuse
    • Terrain addictif et consommateur pathologique de drogues ou d’alcool.
    • Conducteur de machines
    • Prise habituelle ou systématique quotidienne d’antalgique de palier 2 ou 3
    • Allergie à un ou plusieurs des composants
    • Participation à une autre étude interventionnelle
    • Patient recevant déjà d’une corticothérapie
    • Incapacité à donner son consentement éclairé
    • Grossesse, allaitement
    • Femme en âge de procréer sans méthode contraceptive efficace (oestroprogestatif, dispositif intra-utérin).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the proportion of patients with pain intensity below 5 on a numerical scale 24 hours after the emergency visit.
    Intensité de la douleur inférieure à 5 sur une échelle numérique (EN<5) à 24 heures après la consultation/intervention d’urgence.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after the emergency visit
    24 heures après la consultation/intervention d’urgence
    E.5.2Secondary end point(s)
    - Number of analgesic drug step 1 on the World Health Organization analgesic ladder (Paracetamol 1 gramm) or step 2 (Paracetamol 600 mg / Codeine 50mg) taken after the inclusion visit until 72 hours
    - Difference in pain measured by NS between T0 and T1 (24 hours after T0)
    - Kinetics of the pain self-assessed by NS at 6, 12, 24, 48 and 72 hours after T0
    - Patient’s comfort during the complete endodontic treatment measured by the scale "Iowa Satisfaction with Anesthesia Scale" ISAS)
    - Number of injected anesthetic cartridges for clinical silence for the realization of the complete endodontic treatment
    - Number of patients back for the T2 visit.
    - Nombre de prise d’antalgiques de palier 1 (Paracétamol 1G) ou de palier 2 (Paracétamol 600 mg / Codéine 50mg) après consultation initiale, et ce jusqu’à 72h, notés en date et en heure sur le cahier de suivi.
    - La douleur selon les deux groupes par étude de la différence de douleur mesurée par EN entre H-0 (inclusion) et H-24.
    - La cinétique de résolution de la douleur par EN auto-évaluée à 6 heures puis à 12h, 24h, 48h et 72 heures après la consultation/intervention d’urgence
    - Nombre de patients revenus à la consultation à 72h pour le traitement endodontique- Nombre de cartouches d’anesthésie injectées pour obtenir un silence clinique lors de la réalisation du traitement endodontique .
    - Confort de la prise en charge, mesuré par l’échelle « Iowa Satisfaction with Anesthesia Scale » (ISAS) pendant le traitement endodontique
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 72 hours after the emergency visit
    Jusqu'à 72 heures après la consultation/intervention d’urgence
    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 No
    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 No
    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
    Le critère de jugement principal sera mesuré en insu du groupe de randomisation.
    Primary outcome will be assess blindly from randomisation arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Traitement endodontique partiel
    Partial endodontic treatment
    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
    LVLS
    DVDP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months23
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state120
    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)
    None
    Aucun
    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 Decision2015-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-03
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