Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001638-37
    Sponsor's Protocol Code Number:COX2M3M
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-05
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-001638-37
    A.3Full title of the trial
    Comparison of the preventive painkiller effect of etoricoxib and celecoxib after M3M surgery: A randomized, double-masked clinical trial
    Az etoricoxib és a celecoxib preventív fájdalomcsillapító hatásának összehasonlítása alsó bölcsességfogak eltávolítását követően: randomizált, kettős vak klinikai vizsgálat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial related to the effect of different painkillers (etoricoxib and celecoxib). How do these medicaments reduce the pain after the removal of a lower wisdom tooth?
    Fájdalomcsillapítók (etoricoxib és celecoxib) hatását összehasonlító klinikai vizsgálat. Milyen mértékben csökkentik a fájdalmat a vizsgált gyógyszerek az alsó bölcsességfogak eltávolítását követően?
    A.4.1Sponsor's protocol code numberCOX2M3M
    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 SponsorSemmelweis Egyetem Fogorvostudományi Kar Arc- Állcsont- Szájsebészeti és Fogászati Klinika, Budapest
    B.1.3.4CountryHungary
    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 supportSemmelweis Egyetem Fogorvostudományi Kar Arc- Állcsont- Szájsebészeti és Fogászati Klinika Budapest
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSemmelweis Egyetem Fogorvostudományi Kar Arc- Állcsont- Szájsebészeti és Fogászati Klinika Budapest
    B.5.2Functional name of contact pointSemmelweis Egyetem Fogorvostudomány
    B.5.3 Address:
    B.5.3.1Street AddressMária utca 52.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1085
    B.5.3.4CountryHungary
    B.5.4Telephone number0036304010772
    B.5.6E-mailgyurikomlos@yahoo.com
    D. IMP Identification
    D.IMP: 1
    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 Arcoxia 60 mg filmtabletta
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Pharma Hungary Kft.
    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.3.4Pharmaceutical form
    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 INNetoricoxib
    D.3.9.1CAS number 202409-33-4
    D.3.9.3Other descriptive nameETORICOXIB
    D.3.9.4EV Substance CodeSUB16429MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 CELEBREX 200 MG KEMÉNY KAPSZULA
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Kft.
    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.3.4Pharmaceutical form
    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 INNcelecoxib
    D.3.9.1CAS number 169590-42-5
    D.3.9.3Other descriptive nameCELECOXIB
    D.3.9.4EV Substance CodeSUB01143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    postoperative pain
    postoperativ fájdalom
    E.1.1.1Medical condition in easily understood language
    pain arising after the surgical removal of a lower wisdom tooth
    az alsó bölcsességfogak eltávolítása után jelentkező fájdalom
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    to compare the preventive painkiller efficacy of the examined substances (celecoxib and etoricoxib)
    az etnricoxib és a celecoxib preventív fájdalomcsillapító hatásának összehasonlítása
    E.2.2Secondary objectives of the trial
    to evaluate the necessity of the preventive usage of selective COX-2 inhibitors prior to M3M surgery
    felmérni a szelektív COX-2 gátlók preoperatív alkalmazásának szükségét az alsó bölcsességfogak műtéti eltávolítása során
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    female and male patients aged between 18 and 30, without any current medical conditions or existing in the medical history.

    class I and II, A and B positioned (Pell & Gregory) wisdom teeth will be removed (with the exception of Class II B- due to the more invasive surgery a longer healing period is suspected)
    A klinikai vizsgálatba olyan 18 és 30 év közti férfi és nő pácienseket válogatunk be, akik anamnézisében szisztémás betegség nem szerepel.

    A vizsgált pácienseknél olyan alsó bölcsességfogakat távolítunk el, melyek a Pell & Gregory beosztás szerint I. és II. osztályba, illetve A és B pozíciókba sorolhatók. Kivételt képeznek a Class II. B pozíciójú bölcsességfogak, mivel ezek esetében, a nehezített anatómiai viszonyok miatt nagyobb műtéti megterhelésre, és következményesen elhúzódóbb sebgyógyulásra számíthatunk.
    E.4Principal exclusion criteria
    Patients will be excluded if the following conditions exist:

    - patients under medication (we would like to avoid the interactions)
    - patients who have taken any type of a painkiller during the week prior to the surgery
    - smokers (longer healing period is suspected)
    - pregnancy
    - patients in breast feeding period
    - patients with allergy for the examined medicaments
    Az általunk vizsgálni kívánt gyógyszerekkel (szelektív COX-2 gátlók) létrejövő esetleges gyógyszerkölcsönhatások miatt a vizsgálatból kizárjuk azokat betegeket, akik gyógyszeres kezelés alatt állnak, illetve hosszabb ideig gyógyszeres kezelésben részesültek. Továbbá kizárjuk azon betegeket is, akik a tervezett bölcsességfog eltávolítás előtti egy hétben bármilyen típusú fájdalomcsillapító készítményt szedtek. A lassúbb sebgyógyulás és a fokozott posztoperatív komplikációk miatt a vizsgálatban kizárólag nemdohányzó páciensek vesznek részt. Hasonlóképp kizáró oknak számít a várandósság, illetve a szoptatás időszaka, valamint a COX-gátlók iránti túlérzékenység.
    E.5 End points
    E.5.1Primary end point(s)
    The volume of the postoperative pain will be estimated by the patients on a Visual Analog Scale where 0 means no pain et all ad 10 equals the unbearable pain
    A posztoperatív fájdalom mértékét a páciensek VAS (Visual Analog Scale, 0 = nincs fájdalom, 10 = elviselhetetlen mértékű fájdalom) segítségével regisztrálják
    E.5.1.1Timepoint(s) of evaluation of this end point
    pain should be registered in the first 8 hours after the surgery and on the next day of the intervention in three different timepoints (09:00, 15:00 és 21:00)
    a fájdalmat a beavatkozást követő 8 órában óránként, majd másnap 3 megnevezett időpontban (09:00, 15:00 és 21:00) regisztráltatjuk
    E.5.2Secondary end point(s)
    the rate of the discomfort will be registered on a verbal rating scale (VRS-4)
    a betegek a diszkomfort érzet szintjét 4 pontos tünetbecslő skálán (VRS-4) jegyzik fel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    the discomfort should be registered in the first 8 hours after the surgery and on the next day of the intervention in three different timepoints (09:00, 15:00 és 21:00)
    a diszkomfort érzetet a beavatkozást követő 8 órában óránként, majd másnap 3 megnevezett időpontban (09:00, 15:00 és 21:00) regisztráltatjuk
    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 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 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 trial3
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 75
    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 Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    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 state75
    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 the surgical removal of the M3M patients will receive amoxicillin-clavulanic acid (875mg/125mg) for a 1 week therapy and as occasion requires, acetaminophen 500mg (maximum 4x1)
    az alsó bölcsességfog eltávolítást követően a pácienseknél antibiotikus terápiát indítunk (amoxicillin-klavulánsav 875mg/125mg) és sz.sz. fájdalomcsillapítóval látjuk el őket (acetaminophen 500mg, maximum 4x1)
    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 Decision2022-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 07 21:01:08 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA