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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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).

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    Summary
    EudraCT Number:2008-008265-36
    Sponsor's Protocol Code Number:KETOP_C_03968
    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:2009-04-22
    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 number2008-008265-36
    A.3Full title of the trial
    ?Estudio aleatorizado, con doble enmascaramiento, controlado con placebo y de grupos paralelos de la eficacia y la seguridad de dos dosis de comprimidos para chupar de lisinato de ketoprofeno (6,25 mg y 12,5 mg) en pacientes con dolor de garganta?
    A.3.2Name or abbreviated title of the trial where available
    KRYSTAL
    A.4.1Sponsor's protocol code numberKETOP_C_03968
    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 SponsorSANOFI-AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 No
    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 nameketoprofen base equivalent 12.5mg
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    Oropharyngeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNketoprofen base equivalent
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.IMP: 2
    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 No
    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 nameketoprofen base equivalent 6.25mg
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    Oropharyngeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNketoprofen base equivalent
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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 placeboLozenge
    D.8.4Route of administration of the placeboOropharyngeal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    enfermedad respiratoria vías altas: dolor de garganta
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041367
    E.1.2Term Sore throat
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia de una dosis única de comprimidos para chupar de lisinato de ketoprofeno (6,25 mg y 12,5 mg de base de ketoprofeno) con placebo sobre el alivio total del dolor sumado a lo largo de 15 a 120 minutos (TOTPAR15 ? 120) después de la primera toma del fármaco en investigación.
    E.2.2Secondary objectives of the trial
    ?Comparar eficacia de una dosis única de comprimidos para chupar de lisinato de ketoprofeno con placebo después de la primera toma sobre:
    - alivio total del dolor sumado a lo largo de 15 a 360 minutos
    - cambios con respecto a los valores basales en la intensidad del dolor de garganta.
    - cambios con respecto a los valores basales de la irritación de la garganta.
    - los cambios con respecto a los valores basales de la inflamación de la garganta

    ?Comparar el alivio del dolor, la intensidad del dolor de garganta global, la irritación de la garganta y la inflamación de la garganta en la noche de los días 1, 2 y 3

    ?Evaluar la seguridad de los comprimidos para chupar de lisinato de ketoprofeno (6,25 mg y 12,5 mg) y de placebo en la visita de seguimiento el:
    Día 4: acontecimientos adversos y exploración clínica
    Día 7: notificación de los acontecimientos adversos (seguida de una exploración clínica en caso de ser necesaria)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Pacientes varones o mujeres de 18 años en adelante,
    ? Pacientes con un dolor de garganta asociada o no con una infección de las vías respiratorias superiores (IVRA) ? 24 horas y una duración ? 6 días, en ausencia de estreptococos del grupo A,
    ? Signos de amigdalofaringitis (puntuación EAF ? 5) en la inclusión,
    ? Con una puntuación de irritación de la garganta ? 6 (escala ordinal de 0 a 10),
    ? Con una percepción de inflamación de la garganta ? 60 mm (EVA),
    ? Con una intensidad de dolor de la garganta global, como dolor al tragar, evaluada mediante una EVA ? 60 mm,
    ? Consentimiento informado obtenido por escrito al ser incluidos en el estudio,
    ? Capacidad para entender y cumplir el protocolo del estudio.
    E.4Principal exclusion criteria
    ? tratamiento farmacológico local que contuviera un anestésico bucal local, en las 2 horas previas a la inclusión en el estudio
    ? resultados positivos para faringitis por estreptococos del grupo A
    ? toma de analgésicos en las 4 horas previas a la inclusión
    ?uso de algún analgésico de acción prolongada o de liberación lenta en las 12 horas previas a la inclusión
    ? uso de algún tratamiento antiinflamatorio de 8 a 12 horas antes de la inclusión.
    ? uso de antihistamínico de 8 a 12 horas antes de la inclusión
    ? parestesia faríngea
    ? micosis faríngea
    ? antecendente de broncospasmo inducido por ketoprofeno, aspirina u otro antiinflamatorio no esteroideo
    ? Hipersensibilidad al ketoprofeno o sus excipientes
    ? Cualquier enfermedad que pueda afectar a la respiración, como una bronconeumonía o el asma
    ? Indicios de respiración por la boca o de tos incómoda
    ? Enfermedad crónica que requiera un tratamiento antiinflamatorio prolongado
    ? enfermedad crónica que requiera uso prolongado de anticoagulantes o anticoagulantes o antiplaquetarios una semana antes de la inclusión
    ? Úlcera gástrica o duodenal activa
    ? Hepatopatía avanzada
    ? Nefropatía avanzada
    ? Mujeres con embarazo conocido ? de seis meses
    ? cirugía bucal o extracción dental en la semana previa a la inclusión y durante el tratamiento del estudio
    ? enfermedad orofaríngea aguda que precise una intervención urgente.
    ? úlcera bucal, gingivitis o periodontitis con un riesgo elevado de hemorragias
    E.5 End points
    E.5.1Primary end point(s)
    Todos los análisis de eficacia se realizarán en la población ITT
    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) 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 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) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-04-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Pregnant women less than 6 months
    F.4 Planned number of subjects to be included
    F.4.1In the member state106
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 501
    F.4.2.2In the whole clinical trial 835
    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 Decision2009-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-27
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