Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000260-17
    Sponsor's Protocol Code Number:Intermed_Chlorhexidine_sol_0.2%_
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-27
    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 ConcernedGreece - EOF
    A.2EudraCT number2012-000260-17
    A.3Full title of the trial
    A therapeutic equivalence study, comparing two chlorhexidine digluconate formulations, the test formulation Chlorel® Or. T. Sol. 0,2% w / v and the reference formulation Corsodyl® 0.2% w / v Mint Mouthwash.
    Κλινική Μελέτη Αξιολόγησης της Αποτελεσματικότητας Ενός Νέου
    Σκευάσματος Διγλυκονικής Χλωρεξιδίνης (Chlorel® Or. T. Sol. 0,2% w/v) σε Σύγκριση με Προϋπάρχον Σκεύασμα Ίδιας Δραστικής Ουσίας (Corsodyl® 0,2% w/v Mint Mouthwash).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study, comparing the efficacy of two mouthwashes containing
    chlorhexidine digluconate - the test formulation Chlorel® Or. T. Sol. 0,2% w / v and the reference formulation Corsodyl® 0.2% w / v Mint Mouthwash.
    Κλινική μελέτη που συγκρίνει την αποτελεσματικότητα δύο στοματικών
    διαλυμάτων που περιέχουν Διγλυκονική Χλωρεξιδίνη - ενός νέου σκευάσματος (Chlorel® Or. T. Sol. 0,2% w/v) και του αντίστοιχου σκευάσματος που κυκλοφορεί (Corsodyl® 0,2% w/v Mint Mouthwash).
    A.3.2Name or abbreviated title of the trial where available
    INTERMED-CHX-SD2X15
    A.4.1Sponsor's protocol code numberIntermed_Chlorhexidine_sol_0.2%_
    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 SponsorIOULIA & IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.-INTERMED S.A.
    B.1.3.4CountryGreece
    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 supportIOULIA & IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.-INTERMED S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIOULIA & IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.-INTERMED S.A.
    B.5.2Functional name of contact pointRegulatory Affairs department
    B.5.3 Address:
    B.5.3.1Street Address27, Kalyftaki str.
    B.5.3.2Town/ cityKifissia
    B.5.3.3Post codeGR-14564
    B.5.3.4CountryGreece
    B.5.4Telephone number00302106253905
    B.5.5Fax number00302106253906
    B.5.6E-mailintermed@intermed.com.gr
    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 Corsodyl Mint Mouthwash 0.2% w/v
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Consumer Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Oromucosal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHLORHEXIDINE DIGLUCONATE
    D.3.9.1CAS number 18472-51-0
    D.3.9.3Other descriptive nameCHLORHEXIDINE DIGLUCONATE SOLUTION
    D.3.9.4EV Substance CodeSUB11810MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 No
    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 nameChlorel Or. T. Sol. 0.2% w/v
    D.3.4Pharmaceutical form Oromucosal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHLORHEXIDINE DIGLUCONATE
    D.3.9.1CAS number 18472-51-0
    D.3.9.3Other descriptive nameCHLORHEXIDINE DIGLUCONATE SOLUTION
    D.3.9.4EV Substance CodeSUB11810MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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
    Therapeutic equivalence study, comparing two chlorhexidine digluconate
    formulations indicated for inhibition of the formation of dental plaque, as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene.
    Κλινική Μελέτη Αξιολόγησης της Αποτελεσματικότητας Δύο Σκευασμάτων Διγλυκονικής Χλωρεξιδίνης, που ενδείκνυνται για την αναστολή δημιουργίας οδοντικής πλάκας, στη θεραπεία και πρόληψη ουλίτιδας και για τη διατήρηση καλής στοματικής υγιεινής.
    E.1.1.1Medical condition in easily understood language
    Study comparing the efficacy of two formulations used for inhibition of the formation of dental plaque, as an aid in the treatment and prevention of gingivitis and in the maintenance of oral hygiene.
    Μελέτη στην οποία συγκρίνονται δύο σκευάσματα που χρησιμοποιούνται για την αναστολή δημιουργίας οδοντικής πλάκας, στη θεραπεία και πρόληψη ουλίτιδας και για τη διατήρηση καλής στοματικής υγιεινής.
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10063390
    E.1.2Term Oral hygiene
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10058078
    E.1.2Term Tooth plaque
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10018294
    E.1.2Term Gingivitis 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
    The objective of the study is to compare the efficacy and safety of the Test
    and Reference products both containing 0.2%w/v of chlorhexidine digluconate using specific indices (Plaque Index, Gingival Index, Discoloration Index).
    Σύγκριση της αποτελεσματικότητας και ασφάλειας του προϊόντος αναφοράς και ελέγχου χρησιμοποιώντας ειδικούς δείκτες (PI, GI, DI).
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ηealthy male and female volunteers, at least 18 years of age, students of the School of Dentistry of the University of Athens, non-smokers, with high level of oral hygiene(CPITN <2), with no active dental caries and with no removable dental prostheses or fixed or removable orthodontic appliances.
    Τα άτομα που θα συμπεριληφθούν στην μελέτη θα πρέπει να είναι υγιείς ενήλικες, ανεξαρτήτως φύλου, φοιτητές της Οδοντιατρικής Σχολής του ΕΚΠΑ, μη καπνιστές με υψηλό επίπεδο στοματικής υγείας (CPITN <2), χωρίς ενεργές τερηδονικές βλάβες και χωρίς να φέρουν κινητές ή ακίνητες προσθετικές ή ορθοδοντικές αποκαταστάσεις.
    E.4Principal exclusion criteria
    Subjects taking any medication.
    Subjects with history of allergy to chlorhexidine.
    Δεν θα συμπεριληφθούν στο υλικό της μελέτης άτομα που λαμβάνουν οποιαδήποτε φαρμακευτική αγωγή και έχουν ιστορικό αλλεργίας σε οποιοδήποτε από τα συστατικά των προς μελέτη στοματικών διαλυμάτων.
    E.5 End points
    E.5.1Primary end point(s)
    No significant difference between the test and reference group for plaque and gingival bleeding and for discoloration at the end of the study.
    The presence and quantity of plague will be recorded using the plaque index (PI) of Silness and Löe (0-3 rating).
    In the same surfaces and using the same rating (0-3) the gingival inflammation will be evaluated using the gingival index (GI) of Löe and Silness.
    Finally the discoloration index of dental tissues will be recorded (DI-Tilliss TSI et al). The index records discoloration both qualitatively (color intensity) and quantitatively (area-amount).
    Μη σημαντική διαφορά μεταξύ της ομάδας προϊόντος δοκιμής και της ομάδας προϊόντος αναφοράς όσος αναφορά οδοντική πλάκα, αιμορραγία ούλων και αποχρωματισμό στο τέλος της μελέτης.
    Η παρουσία και η ποσότητα της ΟΜΠ θα καταγραφεί με την βοήθεια του δείκτη πλάκας (PI) των Silness και Löe με διαβάθμιση 0-3.
    Στις ίδιες επιφάνειες και με την ίδια διαβάθμιση (0-3) θα αξιολογηθεί η φλεγμονή των ούλων με τη βοήθεια του ουλικού δείκτη (GI) των Löe και Silness.
    Τέλος θα καταγραφεί ο δείκτης δυσχρωμίας των οδοντικών ιστών (DI). O δείκτης αυτός είναι συνδυαστικός και καταγράφει την δυσχρωμία τόσο ποιοτικά (χρωματική ένταση- intensity) όσο και ποσοτικά (έκταση –amount). (Tilliss TSI et al).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Whole study will be completed within approximately 10 weeks.
    O χρόνος συμμετοχής στη μελέτη είναι περίπου 10 εβδομάδες.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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) Yes
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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
    Each subject will complete the study by exit examination at the end of the study, tooth scaling and polishing.
    Η μελέτη θα ολοκληρωθεί αφού κάθε εθελοντής επισκεφτεί το ιατρείο και υποστεί απομάκρυνση ΟΜΠ, αποτρύγωση και στίλβωση.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days70
    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 days70
    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: 15
    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 Yes
    F.3.2Patients No
    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 state15
    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)
    N/A
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-30
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 07 01:52:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA