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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   44335   clinical trials with a EudraCT protocol, of which   7366   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:2007-005819-25
    Sponsor's Protocol Code Number:COV070905
    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:2007-12-26
    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 number2007-005819-25
    A.3Full title of the trial
    A.4.1Sponsor's protocol code numberCOV070905
    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 SponsorLaboratoire BAILLY-CREAT
    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 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 COVATINE(R)
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire BAILLY-CREAT
    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 nameCOVATINE(R)
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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
    ANXIETE
    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
    Objectif principal :
    Evaluer l’efficacité anxiolytique de COVATINE ® par comparaison au placebo et,
    apprécier, au regard de son efficacité, de sa tolérance et de sa sécurité, si la spécialité COVATINE ® peut être mise à disposition des patients hors de la prescription par un médecin dans des formes d’anxiété traditionnellement qualifiées de légères à modérées et identifiées comme telles par les patients.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Les critères d’inclusion dans l’essai sont les suivants :
    § sujets des deux sexes ;
    § âgés de 18 à 75 ans à J0 ;
    § ayant signé le formulaire de consentement pour participer à l’étude ;
    § capables et acceptant de participer à l’étude ;
    § capables et acceptant de répondre aux questionnaires de l’étude ;
    § présentant un score de l’échelle HAD de Zigmond et Snaith ≥ 6 à J0.
    E.4Principal exclusion criteria
    Les critères de non inclusion dans l’essai sont les suivants :
    § score de l’échelle HAD de Zigmond et Snaith < 6 à J0 ;
    § consommation excessive d’alcool définie sur questionnaire CAGE;
    § consommation de psychotropes illicites soit déclarée ou constatée sur test urinaire (opiacés, cocaïne, amphétamines, cannabis) ;
    § toute pathologie médicale ou psychiatrique susceptible d’interférer avec l’étude (état dépressif majeur, troubles paniques, états obsessionnels compulsifs, troubles psychotiques, insuffisance hépatique, cardiaque ou rénale sévère, glaucome, hypertrophie de la prostate) ;
    § toute prise concomitante de médicaments sédatifs ou anxiolytique (définis ainsi dans les mentions légales du VIDAL);
    § antécédents d’allergie ou d’intolérance à la captodiamine ou à l’un des constituants des produits de l’étude ;
    § femme enceinte ou susceptible de l’être ou allaitante ;
    § intolérance au fructose ;
    § patient présentant un syndrome de malabsorption du glucose et du galactose ;
    § patient présentant un déficit en sucrase-isomaltase ;
    § patient présentant un déficit en lactase ;
    § patients atteints de galactosémie ;
    § patients atteints d’une pathologie évolutive mettant en jeu le pronostic vital ;
    § participation actuelle à une autre recherche biomédicale ou dans les 6 mois précédents ;
    § patient n’ayant pas la capacité juridique de donner son consentement.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal de l’étude sera :
    § l’anxiété évaluée à l’aide de l’auto-questionnaire HAD de Zigmond et Snaith (1983) qui comprend 14 items, 7 d'anxiété (A), 7 de dépression (D) ; l’analyse de l’efficacité portant sur les items « anxiété ».

    Les critères secondaires seront :
    § la « Clinical Global Impression » ou CGI, cotée à l’aide de grilles « CGI-Sévérité », « CGI-Amélioration » et « CGI-Index thérapeutique » ;
    § la symptomatologie : - tension, - anxiété, - somnolence, - ralentissement physique, et - ralentissement psychique, dont l’intensité sera évaluée à l’aide d’EVA (échelles visuelles analogiques de 100 mm avec différentiel sémantique) ;
    § les caractéristiques du sommeil, évalués à l’aide du questionnaire de Spiegel ;
    § la satisfaction globale des patients ;
    § la tolérance clinique (examen clinique, PA, FC)

    Par ailleurs, une recherche de psychotropes sera effectuée sur les urines des patients à J0, J+28 et J+45 et les événements indésirables seront colligés, le cas échéant.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo Yes
    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.8.5The 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
    6 mois
    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 months6
    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) No
    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 Information not present in EudraCT
    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 state200
    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 Decision2007-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-29
    P. End of Trial
    P.End of Trial StatusOngoing
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