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    Summary
    EudraCT Number:2012-000156-33
    Sponsor's Protocol Code Number:RBHP_2012_DALLEL
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-13
    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 number2012-000156-33
    A.3Full title of the trial
    Etude du rizatriptan comme prémédication antalgique lors d’une pulpite irréversible.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Traitement médicamenteux contre la rage de dent.
    A.4.1Sponsor's protocol code numberRBHP_2012_DALLEL
    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 supportCHU de Clermont-Ferrand
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportFondation APICIL
    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 pointPoint de contact DRCI
    B.5.3 Address:
    B.5.3.1Street Address58 rue Montalemebert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number330473751195
    B.5.5Fax number330473754730
    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 Yes
    D.2.1.1.1Trade name Maxalt 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderMSD 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 INNRIZATRIPTAN BENZOATE
    D.3.9.1CAS number 145202-66-0
    D.3.9.4EV Substance CodeSUB04258MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboTablet
    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
    la pulpite dentaire irreversible
    E.1.1.1Medical condition in easily understood language
    la rage de dent
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    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
    L’objectif principal de ce projet est de déterminer l’existence d’un rôle antalgique du rizatriptan dans la douleur inhérente à la pulpite irréversible.
    E.2.2Secondary objectives of the trial
    L’objectif secondaire est de valider l’hypothèse d’une potentialisation par l’administration de rizatriptan de l’efficacité de l’anesthésie lors du soin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient âgé de plus de 18 ans et de moins de 60 ans.
    - Patient pour qui le diagnostic de pulpite irréversible a été établi sur une molaire mandibulaire avec une EVA initiale supérieure à 5/10.
    - Patient informé des contraintes de l’étude et ayant donné son consentement écrit.
    - Patient bénéficiant d’un régime de sécurité sociale.
    - Patient maîtrisant correctement le français.
    E.4Principal exclusion criteria
    - Patient présentant au moins une contre-indications au rizatriptan.
    - patient non coopérant, ne parlant pas ou ne lisant pas couramment le français ou dans l’impossibilité de comprendre le principe d’une échelle de douleur,
    - patient toxicomane ou avec des antécédents de toxicomanie,
    - patient dépendant des opiacés ou avec des antécédents de dépendance aux opiacés,
    - prise d’opiacé (dont le tramadol) avant l’admission aux urgences pour soulager la pulpite,
    - troubles cognitifs ou incapables majeurs rendant impossible la compréhension de l’étude et la signature d’un consentement de façon éclairée.
    E.5 End points
    E.5.1Primary end point(s)
    Score de douleur quantifié par le patient sur une échelle visuelle analogique (EVA) de 0 à 100
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0 : administration orale du traitement (Triptan ou placebo)
    T0+20 min
    E.5.2Secondary end point(s)
    Score de douleur quantifié par le patient sur l’EVA, aux temps : Tanesthesie+15 min après la réalisation de l’anesthésie locale, au cours du soin (pulpotomie), Tpulpo+5 min après la fin du soin.
    - Aire sous la courbe des scores EVA mesurée aux temps cités.
    - Taux de patients ayant une réduction d’au moins 50% du score EVA (T0+20 min) par rapport au score à T0.
    - Satisfaction du patient à propos de la prise en charge (échelle de Likert sur 4 points : 0 = pas satisfait du tout ; 1 = modérément satisfait ; 2 = satisfait ; 3 = très satisfait).
    - Satisfaction du praticien à propos de la réalisation des soins (échelle de Likert sur 4 points également)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Score de douleur quantifié par le patient sur l’EVA, aux temps : Tanesthesie+15 min après la réalisation de l’anesthésie locale, au cours du soin (pulpotomie), Tpulpo+5 min après la fin du soin.
    - Aire sous la courbe des scores EVA mesurée aux temps cités.
    - Taux de patients ayant une réduction d’au moins 50% du score EVA (T0+20 min) par rapport au score à T0.
    - Satisfaction du patient à propos de la prise en charge (échelle de Likert sur 4 points : 0 = pas satisfait du tout ; 1 = modérément satisfait ; 2 = satisfait ; 3 = très satisfait).
    - Satisfaction du praticien à propos de la réalisation des soins (échelle de Likert sur 4 points également)
    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 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) 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 No
    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) No
    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
    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 years0
    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 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.1.3Elderly (>=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 Yes
    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 state52
    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 Decision2012-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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