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    Summary
    EudraCT Number:2013-003548-22
    Sponsor's Protocol Code Number:LAEBBA0005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-003548-22
    A.3Full title of the trial
    Four Week Clinical Efficacy of An Ethyl Lauroyl Arginate HCL (LAE) Mouth
    Rinse: Effect on Gingivitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A four week study to evaluate how well a Medical Device mouth rinse
    treats gingivitis compared to a medicine mouth rinse
    A.4.1Sponsor's protocol code numberLAEBBA0005
    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 SponsorJohnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc
    B.1.3.4CountryUnited States
    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 supportJohnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJohnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address185 Tabor Rd, Morris Plains
    B.5.3.2Town/ cityNew Jersey
    B.5.3.3Post code07950
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1908433-6423
    B.5.5Fax number+1973385-7348
    B.5.6E-mailmlynch23@its.jnj.com
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBeecham Group plc. United Kingdom
    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.3.11 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 Yes
    D.2.1.1.1Trade name LISTERINE® Advanced Defence Gum Treatment
    D.2.1.1.2Name of the Marketing Authorisation holderJOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE SAS, ROUTE DE RETORTAT,F-51120 Sezanne, France
    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 nameListerine®Advanced Defence Gum Treatment
    D.3.4Pharmaceutical form Oromucosal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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) Yes
    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 placeboOromucosal solution
    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
    Gingivitis
    E.1.1.1Medical condition in easily understood language
    Inflammation of the gum tissue
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    To determine the efficacy of Listerine®Advanced Defence Gum Treatment (a mouthwash classified as Class IIa medical device already on the market in the EU) on whole-mouth mean gingival bleeding index (BI) scores as an adjunct to brushing through four week of use and to determine whether its performance is comparable to that of an established gingivitis treatment (i.e. Corsodyl® Mint Mouthwash).
    E.2.2Secondary objectives of the trial
    To determine the efficacy of a LAE-containing mouth rinse on wholemouth
    mean modified gingival index (MGI) and plaque index (PI) scores as an adjunct to brushing through one week, two weeks and four weeks of use.
    To determine the efficacy of a LAE-containing mouth rinse on whole mouth mean bleeding index (BI) score as an adjunct to brushing through one week and two weeks of use.
    To determine the effect of a LAE-containing mouth rinse as an adjunct to brushing on extrinsic staining assessment at two and four weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males and females 18 years of age or older.
    2.A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
    3.A mean gingival index ≥ 1.75 according to the Modified Gingival Index.
    4.A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
    5.Bleeding Index ≥ 0.15.
    6.Absence of significant oral soft tissue pathology, excluding plaque induced gingivitis, based on a visual examination and at the discretion of the Investigator.
    7.Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
    8.Absence of fixed or removable orthodontic appliance or removable partial dentures.
    9.Evidence of a personally signed and dated informed consent document.
    E.4Principal exclusion criteria
    1.Known sensitivity to the investigational product ingredients.
    2.Self-reported pregnancy or lactation.
    3.Dental prophylaxis within 2 weeks prior to Screening visit.
    4.History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
    5.Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the whole-mouth mean Bleeding Index
    (BI) at four weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 4 weeks after treatment
    E.5.2Secondary end point(s)
    1.Whole mouth mean modified gingival index (MGI) and plaque index (PI)
    2.Whole-mouth mean bleeding index (BI)
    3.Extrinsic stain assessment at two and four weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Whole mouth mean PI and MGI measured at one week, two weeks and four weeks.
    2.BI at one and two weeks.
    3.Extrinsic stain assessment at two and four weeks.
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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: 21 March 2014
    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 months2
    E.8.9.1In the Member State concerned days7
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state240
    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 Decision2014-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-31
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