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    The EU Clinical Trials Register currently displays   38161   clinical trials with a EudraCT protocol, of which   6268   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004306-42
    Sponsor's Protocol Code Number:2016-1
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-17
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2015-004306-42
    A.3Full title of the trial
    Comparison of the efficacy of treatment of chronic periodontitis with scaling and root-planning alone or in combination with azithromycin - a prospective, double blind, randomised clinical trial
    Primerjava uspešnosti zdravljenja kroničnega parodontitisa z luščenjem in glajenjem zobnih korenin v kombinaciji z azitromicinom ali brez njega, prospektivna, dvojno slepa, randomizirana raziskava
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of treatment of chronic periodontitis with scaling and root-planning alone or in combination with azithromycin - a prospective, double blind, randomised clinical trial
    Primerjava uspešnosti zdravljenja kroničnega parodontitisa z luščenjem in glajenjem zobnih korenin v kombinaciji z azitromicinom ali brez njega, prospektivna, dvojno slepa, randomizirana raziskava
    A.3.2Name or abbreviated title of the trial where available
    Azythromicin as an adjunct for non-surgical treatment of chronic periodontitis
    Azitromicin kot dodatek nekirurškemu zdravljenju kroničnega parodontitisa
    A.4.1Sponsor's protocol code number2016-1
    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 SponsorStomatološka klinika UKC, Ljubljana
    B.1.3.4CountrySlovenia
    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 supportStomatološka klinika UKC, Ljubljana
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStomatološka klinika UKC, Ljubljana
    B.5.2Functional name of contact pointCLinical Trials INformations
    B.5.3 Address:
    B.5.3.1Street AddressHrvatski trg 6
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number0038615224889
    B.5.6E-mailrok.gaspersic@mf.uni-lj.si
    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 Azibiot
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 nameAzibiot
    D.3.4Pharmaceutical form Film-coated 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 INNAZITHROMYCIN
    D.3.9.3Other descriptive nameAZITHROMYCIN DIHYDRATE
    D.3.9.4EV Substance CodeSUB16399MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number524
    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 placeboFilm-coated 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
    Number of remaining deep pockets after treatment of patients with chornic periodontitis
    Število preostalih globokih žepov po zdravljenju bolnikov s kroničnim parodontitisom
    E.1.1.1Medical condition in easily understood language
    Number of remaining deep pockets after treatment of patients with chornic periodontitis
    Število preostalih globokih žepov o zdravljenju bolnikov s kroničnim parodontitisom
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10060945
    E.1.2Term Bacterial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone
    Ugotoviti, ali se število obolelih mest, ki ostanejo po dodatnem zdravljenju z antibiotikom azitromicinom razlikuje od števila obolelih mest po samostojnem odstranjevanju oblog z zobnih korenin
    E.2.2Secondary objectives of the trial
    To determine if the treatment result is dependent on the presence of the most relevant periodontal pathogens (e. g. Aggregibacter actinomycetemcomitans)
    Ugotoviti, ali je učinek zdravljenja odvisen od priostnosti najpomembnejših parodontopatogenih bakterij, npr. Aggregibacter actinomycetemcomitans
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    This will include systemically healthy smokers and non-smokers aged between 25 and 65 years, with untreated, moderate to advanced form of chronic periodontitis ( Armitage 1999), which will have at least 16 teeth and at least 12 teeth suitable for the evaluation (not including wisdom teeth, teeth with orthodontic wires , bridges, crowns and implants ) having at least six sites with probing depth > 4 mm, clinical attachemnt loss ≥ 2 mm, and radiographic bone loss.
    Vključeni bodo sistemsko zdravi kadilci in nekadilci, stari med 25 in 65 let, z nezdravljeno, zmerno do napredovano obliko kroničnega parodontitisa (Armitage 1999), ki bodo imeli najmanj 16 zob in od tega najmanj 12 zob primernih za ovrednotenje (ne vključuje modrostnih zob, zob z ortodontskimi žicami, mostički, prevlekami in implantatov). Na vsaj 6 mestih bo globina sondiranja > 4 mm, klinična izguba prirastišča ≥ 2 mm in rentgensko vidna izguba kosti.
    E.4Principal exclusion criteria
    Excluded will be systemically ill (diabetes, cancer patients, HIV infection, and patients with metabolic bone diseases and diseases that disrupt the processes of wound healing, patients treated with radiation or chemotherapy , immunosuppressants, anti-epileptic drugs, calcium channel blockers, non-steroidal anti-inflammatory drugs, pregnant women and breastfeeding women and patients who have been in the last 12 months treated with antibiotics, allergic or with suspected hypersensitivity to azithromycin , patients who have been in the last year treated due to periodontal disease.
    Izključeni bodo sistemsko bolni (sladkorni bolniki, rakavi bolniki, okuženi z virusom HIV, bolniki z metabolnimi kostnimi boleznimi ter boleznimi, ki motijo procese celjenja ran, bolniki zdravljeni z obsevanjem ali kemoterapijo, imunosupresivi, antiepileptičnimi zdravili, kalcijevimi antagonisti, nesteroidnimi antirevmatičnimi zdravili, nosečnice in doječe matere, pacienti, ki so jih v zadnjih 12 mesecih zdravili z antibiotiki, preobčutljivi ali s sumom na preobčutljivost na azitromicin, pacienti, ki so jih v zadnjem letu zaradi parodontalne bolezni zdravili z luščenjem in glajenjem korenin ali kirurško
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate if the number of diseased sites in patients with advanced chronic periodontitis will be different after adjunctive use of azithromycin in comprisson to mechanical debridement alone
    Ugotoviti, ali se število obolelih mest, ki ostanejo po dodatnem zdravljenju z antibiotikom azitromicinom razlikuje od števila obolelih mest po samostojnem odstranjevanju oblog z zobnih korenin
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months
    3, 6 in 12 mesecev
    E.5.2Secondary end point(s)
    To determine if the treatment result is dependent on the presence of the most relevant pariodontal pathogens (e. g. Aggregibacter actinomycetemcomitans)
    Ugotoviti, ali je učinek zdravljenja odvisen od priostnosti najpomembnejših parodontopatogenih bakterij, npr. Aggregibacter actinomycetemcomitans
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesecev
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 40
    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 state40
    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
    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 Decision2016-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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