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    Summary
    EudraCT Number:2017-001697-42
    Sponsor's Protocol Code Number:OML-III-A
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-001697-42
    A.3Full title of the trial
    Randomized, placebo-controlled, parallel group, double-blind, multi-center Phase III study to assess the inhibition of plaque formation of 0.1% octenidine mouthwash vs placebo in subjects with a gingival index ≤1.5
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, placebo-controlled, parallel group, double-blind, multi-center Phase III study to assess the inhibition of plaque formation of 0.1% octenidine mouthwash vs placebo in subjects with a gingival index ≤1.5
    A.4.1Sponsor's protocol code numberOML-III-A
    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 SponsorSchülke & Mayr GmbH
    B.1.3.4CountryGermany
    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 supportSchülke & Mayr GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFGK Clinical Research GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressHeimeranstr. 35
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80333
    B.5.3.4CountryGermany
    B.5.4Telephone number+49898931190
    B.5.6E-mailinfo@fgk-cro.com
    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 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 name0.1% octenidine mouthwash ("Octenidin Mundspüllösung")
    D.3.2Product code OML
    D.3.4Pharmaceutical form Mouthwash
    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 INNOctenidine dihydrochloride (OCT)
    D.3.9.1CAS number 70775-75-6
    D.3.9.4EV Substance CodeSUB03484MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 placeboMouthwash
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    inhibition of plaque formation
    Hemmung der Plaque-Neubildung
    E.1.1.1Medical condition in easily understood language
    inhibition of plaque formation
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10056984
    E.1.2Term Dental plaque
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstration of superiority of 0.1% octenidine mouthwash (OML, “Octenidin Mundspüllösung”) to placebo (PLAC) in the inhibition of plaque formation
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male and female subjects (aged 18 and older);
    2. Subjects with a total mean gingival index (GI, Löe, 1967) ≤1.5 (0.0-1.5);
    3. Subjects with at least 20 teeth (excluding wisdom teeth) with complete natural “Ramfjord-teeth” or their replacement teeth and 10 natural anterior teeth (excluding teeth provided with prosthetics such as crowns, dental bridges, veneers or large vestibular fillings such as large cervical or frontal teeth fillings; teeth with small interdental and orally oriented fillings are allowed);
    4. Non-pigmented gingiva;
    5. Signed informed consent.
    E.4Principal exclusion criteria
    1. Subjects with severe systemic diseases (e.g. hepatitis, human immunodeficiency virus [HIV] infection, tuberculosis, acute cancer treatment);
    2. Subjects who require endocarditis prophylaxis for dental examination and treatment;
    3. Subjects with caries requiring treatment (e.g. caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
    4. Subjects who have a history of chronic or aggressive periodontitis;
    5. Subjects with current moderate or severe chronic or aggressive periodontitis (periodontal screening index [PSI] >2 in more than 2 sextants or PSI >3);
    6. Subjects showing a GI score of 3 on at least one tooth;
    7. Subjects who underwent oral surgery within 14 days prior to Screening;
    8. Subjects who used antiseptic mouth rinse within 14 days prior to Screening;
    9. Subjects wearing orthodontic appliances and removable dentures (Wire-retainers after orthodontic treatment are allowed);
    10. Subjects treated with antibiotics less than 3 months prior to the baseline examination at Visit 1 and/or planning such treatment for the duration of the study;
    11. Subjects treated with systemically acting corticosteroids or corticosteroids applied via the oral cavity (e.g. asthma sprays);
    12. Subjects who suffer from xerostomia;
    13. Subjects who have a known hypersensitivity or allergy to the test product and its ingredients or to medications that have a similar chemical structure;
    14. Participation of the subject in another clinical study within the last 4 weeks before enrolment in this study;
    15. Incapability of assessing essence and possible consequences of the study (e.g. alcoholism);
    16. Pregnant or breastfeeding women;
    17. Women with childbearing potential except those who fulfill one of the following criteria:
    a. Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum follicle-stimulating hormone [FSH] >40 U/ml);
    b. Postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy);
    c. Continuous and correct application of a highly effective contraception method with a Pearl Index <1% (e.g. implants, depots, oral contraceptives, intrauterine device [IUD]);
    d. Sexual abstinence; whereas sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject;
    e. Confirmation of vasectomy of the sexual partner;
    18. Evidence suggesting that the subject is not likely to follow the study protocol (e.g. lacking compliance).
    E.5 End points
    E.5.1Primary end point(s)
    Total mean plaque index (Silness and Löe, 1964) after 5 days of treatment at Visit 2
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day 5
    E.5.2Secondary end point(s)
    • Bacterial count reduction in saliva after a single administration of OML vs placebo (bacterial count in saliva will be assessed prior to the first administration of study medication and 1 min after the first administration);
    • Change in total mean GI (Löe, 1967) from Visit 1 to Visit 2;
    • Incidence and severity of adverse events (AEs);
    • Incidence of serious adverse events (SAEs);
    • Change in tooth discoloration index from Visit 1 to Visit 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Bacterial count reduction in saliva: on Day 1 (before and 1 min after the first study medication application)
    • Change in total mean gingival index: Day 1, Day 5
    • Incidence and severity of adverse events (AEs): Screening, Day 1, Day 5
    • Incidence of serious adverse events (SAEs): Screening, Day 1, Day 5
    • Change in tooth discoloration index: Day 1, Day 5
    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 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) 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.8.2.4Number of treatment arms in the trial2
    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 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 Yes
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 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 state100
    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 Decision2017-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-14
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