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    Summary
    EudraCT Number:2009-014401-13
    Sponsor's Protocol Code Number:030(B)SC09047
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-014401-13
    A.3Full title of the trial
    Eficacia y seguridad de una formulación libre de alcohol al 0.15% de bencidamina en spray en niños con dolor de garganta. Ensayo randomizado, doble-ciego, controlado con placebo

    Efficacy and safety of an alcohol-free formulation of 0.15% benzydamine spray in children with sore throat. Randomized, double blind, placebo-controlled study
    A.4.1Sponsor's protocol code number030(B)SC09047
    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 SponsorA.C.R.A.F. S.p.A.
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name TANTUM VERDE 0,255 mg/pulsación solución para pulverización bucal
    D.2.1.1.2Name of the Marketing Authorisation holderANGELINI FARMACEUTICA, 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 Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENCIDAMINA HIDROCLORURO
    D.3.9.1CAS number 132-69-4
    D.3.9.2Current sponsor codeAF864
    D.3.9.3Other descriptive nameBENZYDAMINE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.255
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboLocal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dolor de garganta/sore Throat
    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
    evaluación de la actividad analgésica de una nueva formulación en aerosol con una concentración del 0,15% de bencidamina en una sola administración en comparación con el placebo.

    evaluation of the analgesic activity of 0.15% benzydamine spray in single administration compared to placebo.
    E.2.2Secondary objectives of the trial
    i. evaluación de la formulación en aerosol con una concentración del 0,15% de bencidamina y de la tolerabilidad y seguridad de una sola administración en comparación con el placebo;
    ii. evaluación de la formulación en aerosol con una concentración del 0,15% de bencidamina y de la tolerabilidad y seguridad después de tres días de administración.

    i.evaluation of the 0.15% benzydamine spray tolerability and safety in single administration compared to placebo;
    ii.evaluation of the 0.15% benzydamine spray tolerability and safety after a 3-day administration period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    pacientes ambulatorios de ambos sexos, y escolares de entre 6 y 12 años;
    conclusiones objetivas que confirmen el diagnóstico de dolor de garganta (escala de la faringoamigdalitis > 6 puntos);
    inicio de los síntomas de dolor de garganta en los últimos 7 días;
    dolor de garganta entre moderado y grave ("termómetro de dolor para dolor de garganta en niños" > 120mm);
    compromiso de los padres, los representantes legales autorizados o el menor de cumplir con los requisitos del protocolo del estudio;
    Consentimiento informado para participar en el ensayo, por escrito, firmado y fechado por los padres o el representante legal, según la normativa local.

    Patients may be enrolled under the following circumstances:
    ?male and female outpatients, school children 6-12 years old;
    ?objective findings that confirm the sore throat diagnosis (Tonsillo-Pharyngitis Scale > 6 points);
    ?onset of sore throat symptoms within 7 days;
    ?moderate-to-severe sore throat (?Children?s Sore Throat Pain Thermometer? > 120mm);
    ?willingness of the parentss/legally authorized representative/child to comply with the requirement of the study protocol;
    ?Written informed consent to the trial signed and dated by the parentss or legal representative according to the local regulations.
    E.4Principal exclusion criteria
    historial presente o pasado de reacción de hipersensibilidad a la bencidamina o sus componentes, o historial positivo de alergia a fármacos, en particular a los AINE (fármacos antiinflamatorios no esteroides).
    cualquier enfermedad concomitante que afecte a la respiración;
    empleo de cualquier pastilla para la garganta, enjuague bucal o productos que contengan mentol durante las 2 horas previas a la incorporación al estudio, así como de cualquier medicamento "frío" (es decir, descongestionantes, antihistamínicos, expectorantes y antitusivos) durante las últimas 8 horas, y de analgésicos y antipiréticos durante las últimas 6 horas;
    uso crónico de AINE;
    incapacidad de los padres, los representantes legales autorizados o el menor de comprender o utilizar correctamente las escalas para medir el dolor;
    participación del paciente en otro ensayo clínico durante las cuatro semanas previas o en este mismo ensayo con anterioridad.

    Patients cannot enter the trial under the following circumstances:
    ?past/present history of hypersensitivity reaction to benzydamine or its components, or positive history for drug allergy, in particular to NSAIDs;
    ?any concomitant disease that compromises breathing;
    ?use of any throat lozenge, oral rinse, menthol-containing products within 2 hours of study entry, any ?cold? medication (i.e., decongestionant, antihistamine, expectorants, antitussives) within the past 8 hours, analgesic, antipyretic within 6 hours;
    ?chronic use of NSAIDs;
    ?inability by the parents/legally authorized representative/child to comprehend or correctly use the pain rating scales;
    ?patient participating in another device or clinical trial in the previous 4 weeks or previously enrolled in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de evaluación del estudio será la eficacia analgésica de una sola administración (4 nebulizaciones) de 0,15% de bencidamina en comparación con el placebo, evaluada en periodos de 90 minutos.

    The primary endpoint will be the analgesic efficacy of a single administration (4 nebulizations of 0.15% benzydamine compared to placebo, assessed in a 90 min period.
    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 Yes
    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 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) 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    VER EL PROTOCOLO/SEE THE PROTOCOL
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    NIÑOS (6-12 AÑOS)/CHILDREN (6-12 YEARS OLD)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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 Decision2011-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-21
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