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    Summary
    EudraCT Number:2012-005216-26
    Sponsor's Protocol Code Number:Mono-2013
    National Competent Authority:Iceland - IMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-23
    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 ConcernedIceland - IMCA
    A.2EudraCT number2012-005216-26
    A.3Full title of the trial
    A study of the effect of monocaprin in dental adhesive/dental gel on Candida infection in the oral cavity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of dental adhesive/dental gel containing monocaprin on Candida infection in the mouth
    A.4.1Sponsor's protocol code numberMono-2013
    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 SponsorFaculty of Odontology, University of Iceland
    B.1.3.4CountryIceland
    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 supportFaculties of Odontology and Pharmaceutical Science, University of Iceland
    B.4.2CountryIceland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFaculty of Odontology, University of Iceland
    B.5.2Functional name of contact pointW. Peter Holbrook
    B.5.3 Address:
    B.5.3.1Street AddressVatnsmýrarveg 16
    B.5.3.2Town/ cityReykjavik
    B.5.3.3Post codeIS-101
    B.5.3.4CountryIceland
    B.5.4Telephone number3545254850
    B.5.5Fax number3545254874
    B.5.6E-mailphol@hi.is
    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.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameMonocaprin dental paste
    D.3.4Pharmaceutical form Dental paste
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal 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) 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.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameMonocarpin gel
    D.3.4Pharmaceutical form Dental gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal 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) 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
    Chronic atrophic candidosis or denture stomatitis is the commonest form of oral candidosis. It is an opportunistic infection related to an inflammatory process in the mucosal surface beneath dentures and is a common finding among edentulous patients attending dental schools and those resident in homes for the elderly. The prevalence of this type of candidosis has been increasing with more than 50% of subjects in some studies of elderly denture wearers being reported to have candidosis.
    E.1.1.1Medical condition in easily understood language
    A Candida infection in the oral cavity is a common finding among elderly patients attending dental schools and those resident in homes for the elderly.
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    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
    The applicants have been investigating several new methods for treating common conditions of the oral mucosa. One particular area of interest follows on from the demonstration that monocaprin, a derivative of capric acid, is active against oral yeasts and has, therefore, potential as an alternative treatment for oral yeast infections such as chronic atrophic candidosis or denture stomatitis. The aim of this study is to follow on from the previously-demonstrated in vitro anti-candidal activity into a clinical study by incorporating monocaprin into denture adhesives and mucoadhesive hydrogel. These products will then be tested in clinical trials. It is hoped that these denture products would be improved by imparting anti-candidal activity adjacent to the oral mucosa.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study will be carried out at the clinic of the Landakot geriatric hospital and the dental clinic of the Faculty of Odontology at the University of Iceland. Subjects will be selected from the group of patients attending the clinic. Patients will be edentulous in the upper jaw and use their dentures routinely. The study will be explained to each individual by the pharmacy students, with supervision and assistance where necessary. Patients must give their informed consent to the study.
    E.4Principal exclusion criteria
    Participants that are cognitively impared will be excluded from the trial.
    E.5 End points
    E.5.1Primary end point(s)
    There will be 60 participants in the study and they will be divided into three groups with 20 participants in each. Group I will receive treatement with dental adhesive containing monocaprin, group II will receive treament with tissue liner containing monocaprin and Group III will be not receive treatment but will function as control. The study will last for four weeks. The participants will be taught how to use the dental adhesive and the mucoadhesive hydrogel and requested to use the monocaprin-containing preparations daily. Speciments will be taken at the beginning of the study, then in two weeks and in four weeks. Speciments will be taken at the beginning of the study, then in two weeks and in four weeks. Specimens will be collected using standard 1sq cm sponges that have been soaked in sterile saline and, using sterile tweezers, placed on i) the fitting surface of the denture; ii) the dorsum of the tongue and iii) the palatal mucosa for about 15 sec. Swabs are then removed and placed on the surface of agar culture plates. Plates will be transferred to the laboratory in the Faculty of Odontology and incubated at 37°C overnight. Following incubation the swabs will be removed and incubation continued for a further 24 h before the plates will be examined in a stereo-microscope. Colonies of yeasts will be counted.
    Two weeks after the termination of treatment with a monocaprin containing preparation speciments will be taken to evaluated the extent of re-colonisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Speciments will be taken at the beginning of the study, then in two weeks and in four weeks.
    E.5.2Secondary end point(s)
    Speciments will be taken at the beginning of the study, then in two weeks and in four weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two weeks after the termination of treatment with monocaprin containing preparations speciments will be taken to evaluated the extent of re-colonisation.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    There 2 dosage forms containing monocaprin, a dental adhesive and a gel
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days42
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    Two weeks after the termination of treatment with monocaprin containing preparation speciments will be taken to evaluated the extent of re-colonisation.
    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 Decision2013-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-30
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