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    Summary
    EudraCT Number:2019-000736-25
    Sponsor's Protocol Code Number:IB3M.2019
    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:2019-04-30
    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 number2019-000736-25
    A.3Full title of the trial
    Efficacy of Non-Steroidal Anti-Inflammatory (Ibuprofen) Chronotherapy in Healing After Mandibular Third Molar Surgical Extraction – A Randomized Clinical Trial
    Eficacia de la posología de un anti-Inflamatorio no esteroideo (Ibuprofeno) sobre la inflamación y el dolor postoperatorio tras la cirugía del tercer molar inferior. Ensayo Clínico Aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of a decrease of Ibuprofen dosage in wisdom teeth extraction.
    Eficacia de una disminución de la dosis de ibuprofeno en la extracción de cordales.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of NSAIDs dosage in wisdom teeth extraction.
    Eficacia de la posología de AINEs en cirugía de tercer molar
    A.4.1Sponsor's protocol code numberIB3M.2019
    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 SponsorUniversidad Complutense de Madrid
    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 supportUniversidad Complutense de Madrid
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversidad Complutense de Madrid
    B.5.2Functional name of contact pointMaster de Cirugia Bucal
    B.5.3 Address:
    B.5.3.1Street AddressPlaza de Ramon y Cajal 3
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.6E-mailjesus.torres@ucm.es
    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 Ibufen 400
    D.2.1.1.2Name of the Marketing Authorisation holderCinfa
    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 nameIbuprofen 400
    D.3.2Product code M01AE01
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Buccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXIBUPROFEN
    D.3.9.1CAS number 51146-56-6
    D.3.9.4EV Substance CodeSUB07030MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 3000
    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
    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
    The clinical trial will try to understand if the elimination of the ibuprofen dosage in resting phase after surgical third molar extraction not jeopardize the postoperative period .
    El ensayo clínico trata de demostrar si la supresión de la toma de ibuprofeno durante la fase de descanso después de la cirugía del tercer molar no perjudica el postoperatorio.
    E.1.1.1Medical condition in easily understood language
    Clinical trial will explore if low doses of ibuprofen is beneficial instead of normal doses after wisdom teeth extraction.
    El ensayo clínico trata de averiguar si dosis más bajas de ibuprofeno en lugar de la posología normal es beneficiosa para el paciente en cirugías de terceros molares
    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
    Evaluate pain, trismus, swelling and inflamatory citokines after surgical third molar extraction
    evaluar el dolor, apertura, inflamación y citoquinas inflamatorias tras la extracción quirúrgica del tercer molar
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (i) be aged between 18- 35-year-old, (ii) be healthy according to the American Society of Anaesthesiologists (ASA) classification (subject should not have an active infection, trismus hyperthermia, and swelling before surgery and can maintain adequate oral hygiene), (iii) capable to fill out a questionnaire, (iv) be capable to sign an informed consent form. In addition, to standardize the clinical case of the third molar surgical extraction, the indicated teeth should be lower third molar and completely impacted.
    (i)deben ser mayores de edad 18-35 años, (ii)no deben tener ningún tipo de patología sistémica de acuerdo a la American Society of Anaesthesiologist (ASA), (iii) deben ser capaces de rellenar el cuestionario de salud, (iv) deben ser capaces de firmar el consentimiento informado. Además, debe presentar terceros molares inferiores retenidos.
    E.4Principal exclusion criteria
    (i) have a history of systemic diseases (e.g., diabetes mellitus, hypertension, gastric ulcer), (ii) have a severe/serious illness that requires frequent hospitalization, (iii) are smokers, (iv) are pregnant or breast feeding, (v) are taking any medications or are allergic to NSAIDs, (vi) have impaired cognitive or motor function, (vii) are unable to return for evaluations/study recalls.
    (i) presenten historial de enfermedad sistémica, (ii) se encuentren en estado de necesidad de hospitalización, (iii) fumadores, (iv) embarazadas o lactantes, (v) tomen medicación o tengan alergia a los AINE`s, (vi) tengan alguna alteración cognitiva o de la función motora, (vii) no colabore en el estudio por incomparecencia a las visitas de control.
    E.5 End points
    E.5.1Primary end point(s)
    The decrease of pain, trismus and swelling levels compared to normal ibuprofen doses.
    La disminución del dolor, el trismo y la inflamación comparado con la posología habitual de toma de ibuprofeno
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after extraction
    7 días después de la extracción
    E.5.2Secondary end point(s)
    Not applicable
    No aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplicable
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 years3
    E.8.9.1In the Member State concerned months
    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: 60
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state60
    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)
    Provided in protocol
    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 Decision2019-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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