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    The EU Clinical Trials Register currently displays   41450   clinical trials with a EudraCT protocol, of which   6809   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2013-001866-40
    Sponsor's Protocol Code Number:ParoZink01
    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:2014-10-28
    Trial 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 number2013-001866-40
    A.3Full title of the trial
    The effect of Zinc-D-gluconate on bleeding propensity of the periodontium in patients with chronic parodontitis - a randomised, placebo-controlled, double-blind interventional study
    Die Wirkung von Zink-D-Gluconat auf die Blutungsneigung des Zahnhalteapparates bei Patienten mit chronischer Parodontitis – eine randomisierte, placebo-kontrollierte, doppel-blinde Interventionsstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Zinc-D-gluconate on bleeding propensity of the periodontium in patients with chronic parodontitis
    Die Wirkung von Zink-D-Gluconat auf die Blutungsneigung des Zahnhalteapparates bei Patienten mit chronischer Parodontitis
    A.3.2Name or abbreviated title of the trial where available
    ParoZink01
    ParoZink01
    A.4.1Sponsor's protocol code numberParoZink01
    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 SponsorUniversity Hospital Schleswig-Holstein, UKSH Campus Kiel
    B.1.3.4CountryGermany
    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 supportUKSH, Campus Kiel
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportVerla-Pharm Arzneimittel GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUKSH, Campus Kiel
    B.5.2Functional name of contact pointProf. Dr. Christof Doerfer
    B.5.3 Address:
    B.5.3.1Street AddressArnold-Heller-Strasse 3, Bldg. 26
    B.5.3.2Town/ cityKiel
    B.5.3.3Post code24105
    B.5.3.4CountryGermany
    B.5.4Telephone number00494315972780
    B.5.5Fax number00494315974108
    B.5.6E-maildoerfer@konspar.uni-kiel.de
    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 Zink Verla OTC 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderVerla-Pharm Arzneimittel GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameZink Verla OTC 20mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZink-D-Gluconat
    D.3.9.1CAS number 4468-02-4
    D.3.9.3Other descriptive nameZINC GLUCONATE
    D.3.9.4EV Substance CodeSUB15756MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic paradontitis in adults with at least 16 own teeth
    Chronische Parodontitis bei Erwachsenen mit mindestens 16 eigenen Zähnen
    E.1.1.1Medical condition in easily understood language
    Chronic bacterial inflammation of the gingiva
    Chronische bakterielle Entzündung des Zahnfleisches
    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
    Comparison of variation in bleeding propensity of the gingiva between both treatment groups
    Vergleich der Veränderung der klinischen Blutungsneigung der Gingiva zwischen den Behandlungsgruppen
    E.2.2Secondary objectives of the trial
    Comparison of variation in probing depth and loss of attachment between both treatment groups
    Vergleich der Veränderung der klinischen Sondierungstiefe und des Attachmentverlustes zwischen beiden Behandlungsgruppen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Indication: chronic parodontis (PSI 3 and 4)
    Age: 25 to 85 years
    Minimum of gingival bleeding at six different sites
    Minimum of 16 own teeth without relevant supernatant crowns or restauration edges
    Indikation: chronische Parodontitis (PSI 3 und 4)
    Alter: 25 - 85 Jahren
    Blutung ist an mindestens sechs Stellen feststellbar
    Mindestens 16 eigene Zähne ohne relevant überstehende Kronen- oder Restaurationsränder


    E.4Principal exclusion criteria
    Patients requiring acute parodontal or endodontological treatment
    Patients with heart-, kidney, liver diseases, as well as know diabetics and tumor patients, especially patients treated with anticoagulants
    Patients with injuries in the mouth cavity
    Known hypersensitivity against one of the applied IMP or their ingredients or medications with similar chemical structure
    Patients being treated with antibiotics, anticoagulants or antiphlogistic medication 14 days prior to being enrolled in the study
    Pregnancy and breast feeding
    Smoking
    Patienten mit akutem parodontalen oder endodontologischen Behandlungsbedarf
    Patienten mit Herz-, Nieren- oder Lebererkrankungen sowie bekannte Diabetiker und Tumorpatienten, insbesondere Patienten, die Gerinnungshemmer einnehmen
    Patienten mit Verletzungen im Mundraum
    Anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Medikamente oder deren Inhaltsstoffe oder gegenüber Medikamenten mit ähnlicher chemischer Struktur
    Patienten, welche bis 14 Tage vor Versuchsbeginn mit Antibiotika, Antikoagulantien oder entzündungshemmenden Mitteln behandelt wurden.
    Teilnahme an einer anderen klinischen Studie innerhalb der letzten drei Monate vor dem Einschluss
    Patienten, mit einem Gesundheitszustand, der Einfluss auf die Durchführung der klinischen Studie hat (z.B. erhöhtes Bakteriämierisiko und immunsupprimierte Patienten)
    Schwangere und Stillende
    Raucher
    E.5 End points
    E.5.1Primary end point(s)
    Bleeding upon probing and the number of bleeding sites
    Blutung nach Sondierung und die Anzahl blutender Stellen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 20 (+3 days if necessary) of treatment
    Tag 20 (+ 3 Tage falls erforderlich) der Behandlung
    E.5.2Secondary end point(s)
    Probing depth and loss of attachment
    Sondierungstiefe und Attachmentverlust
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 21 (+3 days if necessary) of treatment
    Tag 21 (+ 3 Tage falls erforderlich) der Behandlung
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 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 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 concerned4
    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
    Letzte Visite des letzten Patienten
    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 months4
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 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 state104
    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)
    After study participation patients will be treated according to standardised guidelines
    Die Patienten werden nach Studienende einer den Leitlinien entsprechenden Parodontitisbehandlung zugeführt
    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 Decision2014-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-21
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