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    Summary
    EudraCT Number:2008-005663-34
    Sponsor's Protocol Code Number:EC20081
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-02-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-005663-34
    A.3Full title of the trial
    Ensayo clínico sobre la eficacia de una pauta con amoxicilina/clavulánico 2000/125 mg (GE) cada doce horas, frente a placebo(GC) en la prevención de la infeccion postoperatoria tras la exodoncia de terceros molares totalmente incluidos recubiertos por hueso mandibular (TMI IV).
    A.4.1Sponsor's protocol code numberEC20081
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJoseba Andoni Santamaría Zuazua
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 AUGMENTINE PLUS 1000/62.5 mg comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAMOXICILINA SODICA
    D.3.9.1CAS number 34642-77-8
    D.3.9.3Other descriptive nameAMOXICILLIN SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number437.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANATO POTASIO
    D.3.9.1CAS number 61177-45-5
    D.3.9.3Other descriptive nameCLAVULANATE POTASSIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILINA TRIHIDRATO
    D.3.9.1CAS number 61336-70-7
    D.3.9.3Other descriptive nameAMOXICILLIN TRIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number562.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboProlonged-release tablet
    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
    prevención de la infección postoperatorioa tras la exodoncia de terceros molares totalmente incluidos recubiertos por hueso mandibular
    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
    Conocer si la dosis del antibiótico por via oral, Amoxicilina/ ác. clavulánico 2000/125mg según la pauta propuesta, disminuye la frecuencia de infección tras la exodoncia de TMI incluidos, totalmente cubierto por hueso, tanto en el postoperatorio próximo como tardío.
    E.2.2Secondary objectives of the trial
    - Determinar las complicaciones infecciosas en el grupo experimental (GE) y en el control (GC).
    - Establecer el Riesgo Relativo y Odd ratio en los grupos experimental y control.
    - Establecer el NNT para que un paciente no tenga infección.
    - Medir el efecto propio ajustado, de la exposición a antibiótico y placebo sobre la respuesta infección si/no mediante análisis multivariante.
    - Establecer los acontecimientos adversos y reacciones adversas.
    - Conocer el ratio /riesgo beneficio incluyendo gastos directos sanitarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sujetos sanos, mayores de 18, sin discriminación de sexo, ni raza, (siempre que comprenda correctamente el castellano), con diagnostico de inclusión dentaria del TMI en situación totalmente endoósea que firmen el consentimiento informado
    E.4Principal exclusion criteria
    - Pacientes con riesgo de endocarditis bacteriana, inmunodeprimidos, con prótesis valvulares y ortopédicas.
    - Pacientes que hubieran tomado antibióticos por cualquier circunstancia los diez días anteriores a la intervención quirúrgica.
    - Pacientes con procesos infecciosos agudos desde diez días previos a la intervención quirúrgica del TMI.
    Patologías sistémicas descompensadas: cardíacas, respiratorias, endocrinas, metabólicas, hematológicas.
    Pacientes sometidos a hemodiálisis.
    Pacientes con insuficiencia renal, pacientes con aclaramiento de creatinina <30
    Pacientes con insuficiencia hepática
    Pacientes irradiados en el territorio cervico-maxilo-facial, en tratamiento con quimioterapia, anticoagulantes y modificadores del metabolismo óseo.
    Paciente con sospecha de mononucleosis infecciosa
    Pacientes alérgicos a amoxicilina/ác.clavulánico o a betalactámicos en general (penicilinas o cefalosporinas).
    Pacientes alérgicos al metronidazol.
    Pacientes alérgicos a Ibuprofeno+arginina 600mg y al metamizol.
    Pacientes alérgicos al anestésico articaína.
    Pacientes en tratamiento con bisfosfonatos.
    Pacientes en tratamiento con alopurinol
    Pacientes en tratamiento con probenecid,
    Mujeres embarazadas o con sospecha de estarlo, o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Demográficas:
    - Edad: se registrará la fecha de nacimiento que consta en la Historia Clínica (HC) y la fecha de la intervención. El registro de la edad corresponde a la del paciente el día de la intervención.
    - Sexo: según HC (Hombre/ Mujer).
    - Raza
    Clínicas:
    - Anticonceptivos (si/ no). Se registrará si la paciente estaba en tratamiento en el momento de la intervención.
    - Tabaco: expresado en número de cigarros día. Se consultara sobre la situación habitual en el momento de la intervención.
    - Estado periodontal: medido en mm. Previamente a la intervención, el cirujano realizara el sondaje periodontal con sonda milimetrada SM 13 Bontempi® (0,5mm-11,5mm), registrando los milímetros de profundidad de la bolsa en el molar adyacente anterior en distal, por vestibular y lingual, anotando la cifra mayor.
    Radiológicas:
    - Confirmaremos que el tercer molar a extraer se encuentra totalmente cubierto por hueso midiendo en mm la cortical que recubre al tercer molar.
    - Se registrará la posición respecto al eje axial: angulación mesioangular, distoangular, horizontal, vertical.
    Quirúrgicas:
    - Se registrará el tiempo de duración de la intervención expresado en minutos y segundos, contabilizado desde el inicio de la incisión hasta corte del último punto de sutura. Se empleará un cronómetro .
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 Information not present in EudraCT
    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
    El ensayo se finalizará si:
    Se observan reacciones adversas graves y no esperadas
    Si el análisis intermedio demuestre claramente que el tratamiento es muy superior al placebo lo que plantea un dilema ético. O la evidencia de que el tratamiento se comporta igual que el placebo
    Si no se cumplan los plazos previstos de reclutamiento o el ensayo no se pueda realizar de acuerdo con las normas de la buena práctica clínica
    Si se obtiene información de otros estudios que desaconseje continuar con el
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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 Decision2009-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-27
    P. End of Trial
    P.End of Trial StatusOngoing
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