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    The EU Clinical Trials Register currently displays   35654   clinical trials with a EudraCT protocol, of which   5853   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:2005-000682-19
    Sponsor's Protocol Code Number:FMLD-DICLO2SP-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:2006-04-27
    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 number2005-000682-19
    A.3Full title of the trial
    ENSAYO CLÍNICO ALEATORIZADO, DOBLE-CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA, TOLERABILIDAD Y NIVELES PLASMÁTICOS DE UNA FORMULACIÓN DE DICLOFENACO 2% SPRAY EN EL TRATAMIENTO LOCAL DEL DOLOR AGUDO
    A.4.1Sponsor's protocol code numberFMLD-DICLO2SP-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 SponsorFARMALIDER, 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 nameDICLOFENACO FARMALIDER 2% SPRAY CUTÁNEO
    D.3.4Pharmaceutical form Cutaneous spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdiclofenaco dietilamonico
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous spray, solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    DOLOR LOCAL AGUDO SECUNDARIO A ALTERACIONES MUSCOLOESQUELÉTICAS DE LAS EXTREMIDADES TALES COMO ESGUINCES O DISTENSIONES
    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
    Objetivo principal: Evaluar la eficacia analgésica de diclofenaco Farmalider 2% spray, aplicado 2 veces al día durante un período de 7 días, versus placebo en pacientes con dolor local agudo secundario a alteraciones musculoesqueléticas de las extremidades tales como esguinces o distensiones, utilizando como variable de eficacia la valoración de los cambios en la intensidad del dolor al movimiento utilizando una Escala Analógica Visual (EAV).
    E.2.2Secondary objectives of the trial
    Objetivos secundarios: Los objetivos secundarios de eficacia son: evaluar los cambios en la intensidad del dolor en reposo mediante EAV; evaluar de forma subjetiva, por parte del paciente, su mejoría global utilizando una Escala Verbal Descriptiva (EVD) y evaluar la cantidad de medicación de rescate utilizada.
    Los objetivos secundarios de seguridad son: evaluar la seguridad de la nueva formulación valorando tanto su tolerabilidad local y sistémica, como los niveles plasmáticos que se alcanzan en el estado de equilibrio
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Edad igual o superior a 18 años.
    - Pacientes hombres y mujeres que tras recibir toda la información sobre el diseño del estudio, sus fines y los posibles riesgos que de él pudieran derivarse, así como de que en cualquier momento pueden retirarse del mismo, otorguen su consentimiento por escrito.
    - Sujetos a los que se haya diagnosticado de esguince o distensión de muñeca o tobillo.
    - Sujetos que puedan ser aleatorizados a un grupo de tratamiento dentro de las primeras 48 horas de producirse el traumatismo o lesión.
    - Sujetos que en la visita de pre-aleatorización presenten dolor al movimiento evaluado con puntuación ≥ 30 mm en la EAV.
    E.4Principal exclusion criteria
    - Pacientes que requieran tratamiento quirúrgico de la lesión o la utilización de escayolas o vendajes que impidan la administración de la medicación en estudio.
    - Pacientes que hayan padecido esguince o distensión en la zona actual de la lesión en los 3 meses previos.
    - Pacientes con erosiones, heridas o enfermedades dérmicas en la zona de la lesión.
    - Antecedentes de hipersensibilidad a diclofenaco, ácido acetilsalicílico o a cualquier otro antiinflamatorio no esteroideo utilizado por cualquier vía de administración.
    - Antecedentes de asma, angioedema, urticaria o rinitis desencadenado por el consumo de antiinflamatorios no esteroideos.
    - Antecedentes de úlcera péptica, alteraciones de la coagulación o hemorragia.
    - Pacientes en tratamiento crónico con analgésicos o antiinflamatorios.
    - Pacientes en tratamiento con anticoagulantes o antiagregantes plaquetares.
    - Pacientes tratados con cualquier fármaco en investigación en los 30 días previos.
    - Pacientes en los que en la visita de pre-aleatorización no se pueda instaurar un intervalo mínimo de 6 horas entre el consumo de fármacos analgésicos o antiinflamatorios y la evaluación de la intensidad de dolor.
    - Pacientes que muestren incapacidad para seguir las instrucciones o colaborar durante el desarrollo del estudio.
    - Mujeres embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es el cambio en la intensidad del dolor al movimiento los días 3 y 7 de tratamiento respecto del valor basal (pre-tratamiento) utilizando una EAV.
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Yes
    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 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 months2
    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 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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state106
    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 Decision2005-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-22
    P. End of Trial
    P.End of Trial StatusOngoing
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