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   44335   clinical trials with a EudraCT protocol, of which   7366   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:2005-005453-21
    Sponsor's Protocol Code Number:BUPI02/05
    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:2005-12-15
    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 number2005-005453-21
    A.3Full title of the trial
    Bupivacaína en anestesia odontológica. Estudio comparativo, respecto a la articaína, de su eficacia clínica durante la extracción quirúrgica del tercer molar inferior incluido.
    A.4.1Sponsor's protocol code numberBUPI02/05
    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 SponsorLaboratorios Inibsa S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Information not present in EudraCT
    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 nameBupivacaina 0,5 % con epinefrina 1:200.000
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepinefrina
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Articaina 4% con Epinefrina 1:200.000
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Inibsa, 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.3.1Product nameArticaina 4% con Epinefrina 1:200.000
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepinefrina
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Dolor en intervención odontológica
    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
    1.Evaluar la eficacia clínica de la bupivacaína al 0.5% con epinefrina al 1:200.000, en voluntarios sanos, respecto a la técnica infiltrativa, en comparación con la articaína al 4% con epinefrina al 1:200.000.

    2.Evaluar la eficacia clínica de la bupivacaína al 0.5% con epinefrina al 1:200.000, en voluntarios sanos, en la extracción quirúrgica del tercer molar inferior incluido, en comparación con la articaína al 4% con epinefrina al 1:200.000.
    E.2.2Secondary objectives of the trial
    1.Evaluar los cambios de las constantes hemodinámicas que induce la bupivacaína al 0.5% con epinefrina al 1:200.000, en voluntarios sanos, en la técnica infiltrativa, en comparación con la articaína al 4% con epinefrina al 1:200.000.

    2.Evaluar los cambios de las constantes hemodinámicas que induce la bupivacaína al 0.5% con epinefrina al 1:200.000, en pacientes durante una extracción quirúrgica de un tercer molar inferior incluido,en comparación con la articaína al 4% con epinefrina al 1:200.000.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    *Estudio A:

    Voluntarios sanos (ASA I), de ambos sexos y de edad comprendida entre los 18 y 30 años, reclutados entre los estudiantes de pre y postgrado de la Facultad de Odontología, que tras ser informados, acepten participar en el estudio y que firmen el consentimiento informado.
    En un examen preliminar deberá comprobarse:
    -Índice de masa corporal mayor de 18 e inferior a 30.
    -Frecuencia cardíaca entre 60 y 100 ppm; tensión arterial sistólica inferior a 140 y diastólica superior a 90; saturación de oxígeno superior a 96 (estos valores deben comprobarse en la visita de reclutamiento)
    -Ausencia de cualquier patología sistémica, de antecedentes de hipersensibilidad medicamentosa, y de gestación –incluyendo la posibilidad de estar embarazada, o de lactancia.
    -Ausencia de hábitos tóxicos (incluyendo enolismo, tabaquismo y consumo regular de cannabis) y la toma rutinaria de cualquier tipo de medicación.
    -Ausencia de reacciones adversas relacionadas con la administración de anestésicos locales, en el campo de la odontología o no.
    -Ausencia de patología dentaria (caries o otras alteraciones), de restauraciones, de antecedentes traumáticos, de hipersensibilidad dentaria, y de patologia periodontal en los dientes que van a examinarse; comprobación de vitalidad pulpar positiva de los mismos.
    -Ausencia de infecciones, agudas o crónicas, en el área bucomáxilofacial.

    Estudio B:

    Pacientes ASA I y II, de ambos sexos y de edad comprendida entre los 18 y 40 años, reclutados entre los que acuden al Servicio de Cirugía Bucal de la Clínica Odontológica Universitaria para que se les efectue la extracción de los dos terceros molares inferiores incluidos, y que tras ser informados, acepten participar en el estudio y que firmen el consentimiento informado.
    En un examen preliminar deberá comprobarse:
    -Índice de masa corporal mayor de 18 e inferior a 30.
    -Frecuencia cardíaca entre 60 y 100 ppm; tensión arterial sistólica inferior a 140 y diastólica superior a 90; saturación de oxígeno superior a 96 (estos valores deben comprobarse en la visita de reclutamiento)
    -Ausencia de cualquier patología sistémica grave que implique una limitación funcional.
    -Ausencia de antecedentes de hipersensibilidad medicamentosa.
    -Ausencia de gestación –incluyendo la posibilidad de estar embarazada-, o de lactancia.
    -No dependencia a drogas de abuso.
    -Ausencia de toma rutinaria de cualquier tipo de medicación que pueda interferir con los resultados del estudio o que suponga un riesgo para el paciente.
    -Ausencia de reacciones adversas relacionadas con la administración de anestésicos locales, en el campo de la odontología o no.
    -Presencia de dos terceros inferiores incluidos, de dificultad quirúrgica presumiblemente similar, y que requieran como mínimo levantamiento de un colgajo mucoperióstico, ostectomía y odontosección. Para ello se utilizará la clasificación de Pell y Gregory (valorada en una ortopantomografía), debiendo ser preferentemente de la clase II divisiones A o B.
    -Ausencia de infección aguda presente en el área bucomáxilofacial, tolerándose aquellas que hayan dado manifestaciones clínicas un mes antes de la intervención.
    E.4Principal exclusion criteria
    *Estudio A:

    -Administración de cualquier tipo de fármaco los 15 dias anteriores a la prueba.
    -Administración de anestésicos locales en la región bucomáxilofacial en los 15 dias anteriores a la primera prueba del ensayo.
    -Frecuencia cardíaca inferior a 60 o superior a 110 ppm; tensión arterial sistólica superior a 150 e inferior a 100; tensión arterial diastólica superior a 100 e inferior a 60; saturación de oxígeno inferior a 96 (estos valores han de comprobarse justo antes de empezar la prueba).
    -Tiempo de latencia superior a los 3 minutos en la técnica infiltrativa (en este caso se concede una nueva oportunidad, en otra sesión, puesto que cabe pensar en un error de la técnica anestésica).
    -Cuando el voluntario decida abandonar el estudio. En el caso de producirse un abandono, el sujeto será substituido por otro voluntario, consignándose este evento en las incidencias de la investigación.

    *Estudio B:

    -Presencia de patología inflamatoria/infecciosa o dolor en el momento de la exploración preliminar o antes de la intervención.
    -Administración de cualquier tipo de fármaco los 15 dias anteriores a la prueba.
    -Administración de anestésicos locales en la región bucomáxilofacial en los 15 dias anteriores al ensayo.
    -Frecuencia cardíaca inferior a 60 o superior a 110 ppm; tensión arterial sistólica superior a 150 e inferior a 100; tensión arterial diastólica superior a 100 e inferior a 60; saturación de oxígeno inferior a 96 (estos valores han de comprobarse justo antes de empezar la intervención).
    -Tiempo de latencia superior a los 5 minutos.
    -Cantidad de solución anestésica empleada (incluyendo reanestesias) superior a 4 cartuchos de 1.8cc.
    -Intervención quirúrgica de duración mínima 15 minutos y máxima 45 minutos.
    -Tiempo requerido para ambas intervenciones diferente en un 50%.
    -Incumplimiento de las instrucciones del postoperatorio.
    -Complicaciones intraoperatorias sean locales (hemorragia, fractura, etc.) o sistémicas (lipotimia, convulsiones, etc.).
    -Ausencia de dolor en las primeras 24 horas del postperatorio.
    -Complicaciones postoperatorias como alveolitis seca o supurada, o cualquier forma de infección del área bucomáxilofacial.
    -Cuando el voluntario decida abandonar el estudio. En el caso de producirse un abandono, el sujeto será substituido por otro voluntario, consignándose este evento en las incidencias de la investigación.
    E.5 End points
    E.5.1Primary end point(s)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Triple ciego, experimental, cruzado, longitudinal y prospectivo, y con medidas intrasujeto.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    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 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)
    Tratamiento habitual previsto para patología
    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 Decision2006-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-16
    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-Sat May 10 02:43:13 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA