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    Summary
    EudraCT Number:2017-004986-28
    Sponsor's Protocol Code Number:AMOXI
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-004986-28
    A.3Full title of the trial
    Effect of systemic antibiotic therapy on postoperative complications in patients undergoing wisdom teeth removal surgery. A double-blind, randomised, placebo-controlled Trial
    Auswirkung einer systemischen Antibiose auf die Patientenbefindlichkeit nach Weisheitszahnentfernung. Eine doppelblinde, randomisierte, Placebo kontrollierte klinische Prüfung.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of the usage of antibiotic treatment in patients undergoing wisdom teeth removal surgery
    Auswirkung der Einnahme von Antibiotika bei Weisheitszahnentfernungs-Operationen.
    A.3.2Name or abbreviated title of the trial where available
    AMOXI
    A.4.1Sponsor's protocol code numberAMOXI
    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 SponsorMedizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProf PD DDr. Michael Payer
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressBillrothgasse 4
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8010
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316385 80659
    B.5.6E-mailmi.payer@medunigraz.at
    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 Amoxilan 1000 mg-Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderG.L. Pharma GmbH, 8502 Lannach
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAmoxilan 1000 mg-Tabletten
    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 INNAMOXICILLIN
    D.3.9.1CAS number 61336-70-7
    D.3.9.2Current sponsor codeAnstaltsapotheke des LKH-­Univ. Klinikum Graz
    D.3.9.3Other descriptive nameAMOXICILLIN TRIHYDRATE
    D.3.9.4EV Substance CodeSUB00504MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboCapsule, hard
    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
    Surgical extraction of third molars
    operative Weisheitszahnentfernung
    E.1.1.1Medical condition in easily understood language
    Extraction of wisdom teeth
    Weisheitszahnentfernung
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047991
    E.1.2Term Wisdom teeth removal
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038349
    E.1.2Term Removal of wisdom teeth
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 whether the perioperative usage of antibiotics is effective in reducing postoperative complications, compared to placebo, in patients undergoing wisdom teeth removal.
    Evaluierung, ob eine perioperative Antibiotikagabe bei Weisheitszahnoperationen einen zusätzlichen Benefit im Hinblick auf eine Reduktion von postoperativen Komplikationen bewirkt, verglichen mit Placebo, bei Patienten nach operativen Weisheitszahnentfernungen.
    E.2.2Secondary objectives of the trial
    Experience of pain, swelling and bleeding
    Auftreten von Schmerzen, Schwellungen, Blutungen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Symptom-free, bilaterally located third molars
    -Medically healthy patient ≥ 16 years
    - No allergies/intolerances against the investigational product/placebo
    - Informed consent
    •Symptomfreie, beidseitig angelegte OK/UK Weisheitszähne
    •≥ 16 Jahre alt
    •Medizinisch gesunder Patient
    •Keine Allergie gegen Amoxicillin oder Penicillin und/oder Lactosum monohydricum PHE und/oder Gelatine
    •Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung
    E.4Principal exclusion criteria
    -General contraindications to wisdom tooth extraction surgery
    -(Former) heavy smoking
    -Use of antibiotics within the last three months or patients requiring antiobiotic treatment prior to surgery
    -(Planned) Pregnancy/lactating
    -Allgemeine Kontraindikationen für operative Weisheitszahnentfernungen
    -(Ehemaliges) starkes Rauchen
    -Anwendung von Antibiotika innerhalb der letzten 3 Monate oder Patienten die eine Antibiotikaprophylaxe vor dem Eingriff benötigen
    •Schwangere oder Patientinnen die planen schwanger zu werden oder zu stillen
    E.5 End points
    E.5.1Primary end point(s)
    Inflammatory complications (swelling, purulence, mouth opening restriction)
    Entzündliche Komplikationen (Schwellung, Pusentleerung, Mundöffnungseinschränkung)
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days post surgery
    7 Tage post OP
    E.5.2Secondary end point(s)
    Occurrence of pain, bleeding, swelling
    Auftreten von Schmerz, Blutung, Schwellung
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 days post surgery
    7 Tage post OP
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Split-mouth design
    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 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
    Letzte Visite des letzten Studienpatienten
    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 months8
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state59
    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)
    According to local standard care
    Gemäß lokaler Standardbehandlung
    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 Decision2019-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-06
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