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    Summary
    EudraCT Number:2008-000990-39
    Sponsor's Protocol Code Number:V00109 DI 301
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-17
    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 ConcernedEstonia - SAM
    A.2EudraCT number2008-000990-39
    A.3Full title of the trial
    Reduction of the gingival inflammation by V0109 DI. Randomised, parallel groups, double blind study, V0109 DI versus placebo, in patients presenting gingivitis.
    A.4.1Sponsor's protocol code numberV00109 DI 301
    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 SponsorPIERRE FABRE MEDICAMENT
    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 Yes
    D.2.1.1.1Trade name ARTHRODONT
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    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.3.2Product code V0109 DI
    D.3.4Pharmaceutical form Gingival paste
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPDental use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXOLONE
    D.3.9.1CAS number D03AX10
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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) 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 placeboGingival paste
    D.8.4Route of administration of the placeboDental use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reduction of the gingival inflammation by V0109 DI.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10012325
    E.1.2Term Dental and periodontal infections and inflammations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of V0109 DI in reducing gingival inflammation in patients with gingivitis.
    E.2.2Secondary objectives of the trial
    - To assess the effect of V0109 DI on gingival bleeding,
    - To assess the activity of V0109 DI on dental plaque,
    - To assess the local and general tolerance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Will be eligible patients (male or female) who meet the following criteria:
    - age between 18 and 45 years inclusive,
    - negative urine pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (oral contraception, intrauterine device, tubal ligature) since at least 2 months before the screening and until 1 month after the end of the study,
    - stable hormonal contraception since least 2 months before the screening visit and not start it during the study,
    - be non smoker,
    - have a minimum of 20 natural teeth ( excluding wisdom teeth) and good dental health (except gingivitis),
    - have a toothbrush and toothpaste,
    - have gingivitis (Gingival Index > or equal to 1,5),
    - willing and able to understand and sign an approved Informed Consent Form,
    - able to understand the protocol and to attend the control visits,
    - registered with a social security or health insurance system if required by law.
    E.4Principal exclusion criteria
    Will not be included patients who have one of the following criteria:
    * Criteria related to pathology
    - periodontitis,
    - history of periodontitis or acute necrotizing ulcerative gingivitis,
    - history of severe medical or psychiatric disease/disorder which, in the judgement of the investigator, puts the patient « at risk » or is likely to modify the handling of the study drug,
    - epilepsy,
    - any coagulation disorder,
    - hyposialia or asialia,
    - caries with cavities and ill-fitting restorations,
    - lichen planus,
    - current signs or symptoms of mucosal tissue ulcerations, or canker sores,
    *Criteria related to treatments
    - currently undergoing orthodontic treatment,
    - extensive interproximal restorations, crowns, bridges or implants,
    - treatment within the six weeks preceding inclusion with either :· antibiotics· corticosteroids· non-steroidal anti-inflammatory drugs· immunosuppressive drugs, immunostimulant drug, antimitotic drug,
    - start or change within the preceding month of any drug which could interfere with salivary flow: anticholinergic drug, atropine, scopolamine, quaternar amoniums, imipraminic antidepressives, sedative antihistamines, phenothiazines neuroleptics, disopyramide,
    - treatment with any other topical product (i.e. mouthwashes, gels,…) which could interfere with the study treatment,
    * Criteria related to the way of life
    - Drinking excessive amounts of alcohol (more than 2 glass of wine (>2) per day or equivalent),
    - history of drug addiction,
    * Criteria related to the population
    - female who is pregnant or breast feeding or not using contraception, or planning to become pregnant,
    - participation to an other clinical trial in the previous month before the inclusion visit or during the study,
    - patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,
    - patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship,
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Primary criterion
    The main criterion will be the evolution of the Loe and Silness Gingival Index (GI) during the study: mean change between D0 and D14 calculated on 6 sites (3 vestibular and 3 palatin) around 6 target teeth, excluding wisdom teeth.
    Safety
    - local tolerance: aspect of the mouth mucosa,
    - general tolerance (adverse events),
    Statistical analysis
    - efficacy:non-parametric analysis of covariance,
    -safety: descriptive analysis.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) 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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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 Decision2008-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-12
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