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    Summary
    EudraCT Number:2012-002236-87
    Sponsor's Protocol Code Number:RH01561
    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:2012-06-07
    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 number2012-002236-87
    A.3Full title of the trial
    Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes
    A.4.1Sponsor's protocol code numberRH01561
    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 SponsorGlaxoSmithKline Consumer Healthcare
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Consumer Healthcare
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Consumer Healthcare
    B.5.2Functional name of contact pointGSK CH Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressSt Georges Avenue
    B.5.3.2Town/ cityWeybridge
    B.5.3.3Post codeKT13 0DE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4401932822350
    B.5.5Fax numberN/AN/AN/A
    B.5.6E-mailrd.gskch-clinical-trials@gsk.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 Yes
    D.2.1.1.1Trade name Corsodyl Mint Mouthwash
    D.2.1.1.2Name of the Marketing Authorisation holderBeecham Group Plc trading as GlaxoSmithKline 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.3.1Product nameCorsodyl Mint Mouthwash - alcohol containing
    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.3.9.1CAS 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 Yes
    D.2.1.1.1Trade name Corsodyl 0.2% Mouthwash
    D.2.1.1.2Name of the Marketing Authorisation holderBeecham Group Plc trading as GlaxoSmithKline 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.3.1Product nameCorsodyl Mint Mouthwash - alcohol free
    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.3.9.1CAS 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
    Gingival bleeding and gingivitis
    E.1.1.1Medical condition in easily understood language
    Gum bleeding and gum inflammation
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10018292
    E.1.2Term Gingivitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10018276
    E.1.2Term Gingival bleeding
    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
    To evaluate and compare Gingival Bleeding (as assessed by the gingival severity component of the Gingival Index [GI]) following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.
    E.2.2Secondary objectives of the trial
    To evaluate and compare Gingivitis (as assessed by the Gingival Index) following twice daily use of a non-alcohol 0.2% Chlorhexidine (CHX) mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.

    To evaluate and compare plaque control (overall and interproximal dental plaque scores) using Turesky modification of Quigley & Hein plaque index following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consent

    Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

    2. Age

    Aged at least 18 years and not over 64 years.

    3. Compliance

    Understands and is willing, able and likely to comply with all study procedures and restrictions.

    4. General Health

    Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.

    5. Dental Health

    a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).

    b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).

    c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.

    d) Positive response to bleeding on brushing exercise at screening visit.

    e) A total of 20 bleeding sites or greater at baseline visit.

    6. Contraception

    Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
    E.4Principal exclusion criteria
    1. Pregnancy

    Women who are pregnant, intending to become pregnant or who have a positive urine pregnancy test at the screening, baseline or prophylaxis visits.

    2. Breast-feeding

    Women who are breast–feeding.

    3. Allergy/Intolerance

    Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.

    4. Clinical Study/Experimental Medication

    a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

    b) Previous participation in this study.

    5. Medical History/ Current Medications

    a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.

    b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy.

    c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).

    d) Use of antibiotics within two weeks prior to the screening visit or throughout the study.

    e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy)

    6. Dental Health

    a) Have current active caries

    b) More than 3 pockets with 5mm or over.

    c) Excessive calculus present that interferes with the probing examination for Gingival Index.

    d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.

    e) Medical conditions which may directly influence gingival bleeding.

    f) Restorations in a poor state of repair.

    g) Orthodontic appliances anterior cosmetic restorations and veneers.

    h) Enamel pitting/irregularities.

    7. Tobacco Chewers

    Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.

    8. Substance abuse

    Recent history (within the last year) of alcohol or other substance abuse.

    9. Personnel

    a) An employee of the sponsor or the study site or members or their immediate family.

    b) An employee of any toothpaste manufacturer or their immediate family.
    E.5 End points
    E.5.1Primary end point(s)
    Gingival Severity Index (a component of the Gingival Index assessing the proportion of bleeding sites)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.5.2Secondary end point(s)
    -Gingival index score

    - Overall plaque score (Turesky Modification of the Quigley Hein Index)

    - Interproximal plaque score (Turesky Modification of the Quigley Hein Index)
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 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 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) 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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stratified
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Toothbrushing with a sodium fluoride toothpaste
    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 concerned2
    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 plus 5 days for follow up of adverse events
    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
    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: 360
    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 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 state360
    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)
    On conclusion of the study, subjects will be offered a dental prophylaxis by a dental professional to remove stain that may have accumulated during the course of the study.
    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 Decision2012-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-01
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