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    Summary
    EudraCT Number:2012-003430-16
    Sponsor's Protocol Code Number:OC004PDS
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-11-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-003430-16
    A.3Full title of the trial
    Effect of local anesthesia in patients with marginal periodontitis undergoing subgingival scaling
    Effekt af lokalanalgesi ved subgingival depuration af patienter med marginal parodontitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of local anesthesia in patients with chronic gingivitis undergoing dental cleanings
    Effekt af lokalbedøvelse ved tandrensninger hos patienter med kronisk tandkødsbetændelse
    A.3.2Name or abbreviated title of the trial where available
    PSD Lozenge
    A.4.1Sponsor's protocol code numberOC004PDS
    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 SponsorClinical Reasearch Centre, Hvidovre University Hospital
    B.1.3.4CountryDenmark
    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 supportOracain II Aps
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Centre, Hvidovre University Hospital
    B.5.2Functional name of contact pointStine Mogensen
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post codeDK-2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538626077
    B.5.5Fax number004538623797
    B.5.6E-mailsugetablet@gmail.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 nameBupizenge
    D.3.2Product code BUPI25
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 18010-40-7
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeLocal anaesthetics for for oromucosal use
    D.IMP: 2
    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 Xyloplyin Dental Adrenalin
    D.2.1.1.2Name of the Marketing Authorisation holderDentsply Limited
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameXyloplyin Dental Adrenalin
    D.3.4Pharmaceutical form Injection
    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 51-43-4
    D.3.9.3Other descriptive nameADRENALINE
    D.3.9.4EV Substance CodeSUB15951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameLIDOCAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Pain and discomfort during dental treatment in patients with periodontitis
    Smerte og ubehag ved tandrensning hos patienter med parodontitis
    E.1.1.1Medical condition in easily understood language
    Pain and discomfort during dental treatment in patients with chronic gingivitis
    Smerte og ubehag ved tandrensning hos patienter med kronisk tandkødsbetændelse
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10009102
    E.1.2Term Chronic periodontitis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration
    At påvise at sugetabletten ikke har en dårligere lokalbedøvende effekt i forhold til injektionen ved subgingival depuration
    E.2.2Secondary objectives of the trial
    The patient evaluates
    - the pharmaceutical form of the two local anesthetic
    - the taste and texture of the lozenge
    The dentist evaluates the depuration
    Patienten vurderer
    - dispenseringsformen af de to lokalbedøvelser
    - smag og konsistens af sugetabletten
    Tandlægen vurderer depurationen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe
    - Age between 18 and 80 years
    - Ability to speak, read and understand danish
    - Ability to give oral and written consent
    - Patienter diagnosticeret med hhv. parodontitis marginalis adulta progressiva lenta og parodontitis marginalis adulta progressiva rapida i hygiejnefasen, hvor depurationer gentages indenfor en kort tidsramme
    - Alder over 18 år
    - Skal være i stand til at tale, læse og forstå dansk
    - Skal være informeret mundtligt og have afgivet skriftligt samtykke, samt underskrevet fuldmagtserklæring
    E.4Principal exclusion criteria
    -Known allergy to bupivacaine or other local anaesthetics of the amide type
    -Other gingival infections (eg lichen planus)
    -Pregnancy -if in doubt a pregnancy test will be made
    -Breastfeeding
    -Kendt allergi overfor bupivacain eller andre lokalanalgetika af amidtypen.
    -Andre gingivale infektioner (fx lichen planus)
    -Graviditet. Ved tvivl udføres en graviditetstest.
    -Ammende.

    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration
    The patient scores the level of pain by:
    -Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain.
    -McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.
    The patient scores the level of discomfort by:
    -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.
    Det primære effektmål er at påvise at sugetabletten ikke har en dårligere lokalbedøvende effekt i forhold til injektionen ved subgingival depuration vurderet udfra:
    - Patientens smerte målt ved Visuel Analog Skala (VAS) 0-10 hvor 0 = ingen smerte og 10 = ekstrem smerte
    - McGills Pain Questionnaire (MPQ) hvor der tegnes en kvalitativ smerteprofil.
    - Patientens ubehag målt ved Visuel Analog Skala (VAS) 0-10, hvor 0 = intet ubehag og 10 = ekstremt ubehag.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The patient evaluates pain and discomfort before, during and after the depuration by VAS and MPQ.
    Patienten vurderer smerte og ubehag før, under og efter depurationen ved VAS og MPQ.
    E.5.2Secondary end point(s)
    The patient evaluates
    - the pharmaceutical form of the two local anesthetic using a questionnaire
    - the taste and texture of the lozenge using a questionnaire
    The dentist evaluates the depuration using a questionnaire
    Patienten vurderer
    - dispenseringsformen af de to lokalbedøvelser vha. spørgeskema
    - smag og konsistens af sugetabletten vha. spørgeskema
    Tandlægen vurderer
    - depurationen vha. et spørgeskema
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The patient evaluates the pharmaceutical forms after the depuration
    - The patient assesses taste and texture of the lozenge after the depuration
    - The dentist evaluates the depuration after the procedure
    - Patienten vurderer dispenseringsformen af de to lokalbedøvelser efter depurationen
    - Patienten vurderer smag og konsistens af sugetabletten efter depurationen
    - Tandlægen vurderer depurationen efter proceduren
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Optimization of the anesthetic method when performing a subgingival depuration
    Optimering af bedøvelsesmetoden ved subgingival depuration
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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
    The trial ends August 2013
    Forsøget afsluttes august 2013
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-11-15. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    According to F.3.3.1, if in doubt pregnancy test will be done
    Jævnfør F.3.3.1, ved tvivl vil en graviditetstest blive udført
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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
    Ingen
    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 Decision2012-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-06-19
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