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    Summary
    EudraCT Number:2016-002611-18
    Sponsor's Protocol Code Number:KF7019-01
    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:2018-02-19
    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 number2016-002611-18
    A.3Full title of the trial
    An exploratory, randomized, double-blind, double-dummy, placebo- and active-controlled Phase II trial to evaluate the efficacy and safety of a topical application of GRT7019 in subjects with chronic pain due to knee osteoarthritis
    Ensayo de Fase II, exploratorio, aleatorizado, en doble ciego y con doble simulación, controlado con placebo y con producto activo, para evaluar la eficacia y la seguridad de la aplicación tópica de GRT7019 en sujetos con dolor crónico por gonartrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lidocaine/diclofenac epolamine patch (GRT7019) Phase II proof-of-concept trial in patients with chronic pain due to knee osteoarthritis.
    A.4.1Sponsor's protocol code numberKF7019-01
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1184-3912
    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 SponsorGrünenthal GmbH
    B.1.3.4CountryGermany
    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 supportGrünenthal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGrünenthal Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.3.4CountryGermany
    B.5.4Telephone number00492415693223
    B.5.6E-mailClinical-Trials@grunenthal.com
    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 nameLidocaine 700 mg / Diclofenac epolamine 182 mg Patch
    D.3.2Product code GRT7019
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    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 INNLIDOCAINE
    D.3.9.1CAS number 137-58-6
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiclofenac epolamine
    D.3.9.1CAS number 119623-66-4
    D.3.9.3Other descriptive nameDICLOFENAC EPOLAMINE
    D.3.9.4EV Substance CodeSUB20558
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number182
    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.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 Yes
    D.2.1.1.1Trade name Versatis 5% medicated plaster
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Medicated plaster
    D.3.4.1Specific paediatric formulation No
    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 INNLIDOCAINE
    D.3.9.1CAS number 137-58-6
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Diclo 75 SL - 1A Pharma
    D.2.1.1.2Name of the Marketing Authorisation holder1A Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Modified-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiclofenac sodium
    D.3.9.1CAS number 15307-79-6
    D.3.9.3Other descriptive nameDICLOFENAC SODIUM
    D.3.9.4EV Substance CodeSUB01674MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Pantoprazol-ratiopharm 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPantoprazol sodium sesquihydrate
    D.3.9.1CAS number 164579-32-2
    D.3.9.3Other descriptive namePANTOPRAZOLE SODIUM SESQUIHYDRATE
    D.3.9.4EV Substance CodeSUB21564
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22.6
    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 placeboMedicated plaster
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    osteoarthritis
    osteoartritis
    E.1.1.1Medical condition in easily understood language
    osteoarthritis
    osteoartritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the analgesic efficacy of a once daily application of GRT7019 for 4 weeks compared to placebo.
    Evaluación de la eficacia analgésica de una aplicación diaria de GRT7019 durante 4 semanas en comparación con placebo.
    E.2.2Secondary objectives of the trial
    Further characterization of the efficacy of GRT7019, oral diclofenac, lidocaine patch, and placebo.
    Evaluation of the quality of life after treatment with GRT7019, oral diclofenac, lidocaine patch, and placebo.
    Evaluation of the safety and tolerability of GRT7019, oral diclofenac, lidocaine patch, and placebo.
    Determinación adicional de la eficacia de GRT7019, diclofenaco oral, lidocaína en parches y placebo.
    Evaluación de la calidad de vida tras el tratamiento con GRT7019, diclofenaco oral, lidocaína en parches y placebo.
    Evaluación de la seguridad y la tolerabilidad de GRT7019, diclofenaco oral, lidocaína en parches y placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has given written informed consent to participate.
    2. Male or female subject aged 40 years to 80 years, inclusive, at the Enrollment Visit (Day -14 to Day -7).
    3. Body mass index (BMI) between 20 kg/m2 and 36 kg/m2 inclusive, with a minimal body weight of 55 kg at the Enrollment Visit.
    4. Diagnosis of OA of the index knee (the one under investigation) based on American College of Rheumatology (ACR) criteria and functional capacity class of I-III and pain must be present for at least 3 months before the Enrollment Visit according to prior/concomitant diseases and surgical interventions.
    5. Use of medically acceptable methods of contraception and willingness to use them during the trial if the subject or the partner of the subject is a woman of childbearing potential.
    6. Subject must be on stable analgesic medications for their condition with regular intake for at
    least 3 months prior to the Enrollment Visit according to their prior/concomitant diseases and
    surgical interventions.
    7. No intake of rescue medication during the last 3 days prior to the Baseline Visit (Day 1) (to be checked at the Baseline Visit).
    8. A baseline average pain intensity of equal to or above 4 and below 8 on the NRS at the Baseline Visit on Day 1 (as calculated by the electronic diary [eDiary]).
    9. Subject completed at least 5 out of 6 possible morning and evening pain intensity assessments during the last 3 days prior to the Baseline Visit and including the morning of the Baseline Visit (as calculated by the eDiary).
    1. El sujeto ha otorgado su consentimiento informado por escrito para participar.
    2. Sujetos de ambos sexos, de 40 a 80 años (ambos extremos incluidos) en la Visita de Reclutamiento (Día -14 a Día -7).
    3. Índice de masa corporal (Body mass index, BMI) entre 20 kg/m2 y 36 kg/m2 (ambos extremos incluidos), con un mínimo de peso corporal de 55 kg en la Visita de Reclutamiento.
    4. Diagnóstico de artrosis en la rodilla índice (la rodilla objeto del estudio) según los
    criterios del American College of Rheumatology (ACR) y clase I-III de capacidad funcional, con
    dolor presente durante como mínimo los 3 meses anteriores a la Visita de Reclutamiento de acuerdo
    con las enfermedades previas/concomitante y las intervenciones quirúrgicas.
    5. Empleo de métodos anticonceptivos médicamente adecuados y voluntad de utilizarlos durante el
    ensayo si la sujeto o la pareja del sujeto es una mujer potencialmente fértil.
    6. El sujeto debe estar con un tratamiento analgésico estable de su enfermedad, con tomas regulares durante como mínimo en los 3 meses previos a la Visita de Reclutamiento en función de sus enfermedades e intervenciones quirúrgicas previas/concomitantes.
    7. El sujeto no debe haber recibido medicación de rescate durante los últimos 3 días antes de la Visita Basal (Día 1) (a verificar en la Visita Basal).
    8. Intensidad promedio del dolor en el momento basal igual o mayor de 4 y menor de 8 en la NRS en la Visita Basal del Día 1 (calculada mediante el diario electrónico [eDiary]).
    9. El sujeto ha completado como mínimo 5 de las 6 evaluaciones posibles de la intensidad del dolor matutino y nocturno durante los 3 últimos días antes de la Visita Basal, incluida la mañana de la Visita Basal (de acuerdo al eDiary).
    E.4Principal exclusion criteria
    1. Concurrent participation in another trial, or within 30 days before the Enrollment Visit of this trial. Depending on the nature of the previous investigational medicinal product (IMP), a longer washout may be needed.
    2. Evidence or history of alcohol or drug abuse including positive or missing drugs of abuse test at the Enrollment Visit.
    3. Woman of childbearing potential with a positive or missing urine β-human chorionic gonadotropin (β-hCG) pregnancy test at the Enrollment Visit.
    4. Past or pending litigation due to chronic pain or disability.
    5. Employees of the investigator, trial site, or sponsor, with direct involvement in the proposed trial or other trials under the direction of that investigator, trial site, or sponsor, as well as family members of employee or the investigator.
    6. Any clinically significant disease that in the investigator’s opinion may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation, e.g., non-stabilized hypertension, significant pulmonary, gastrointestinal (GI), endocrine, metabolic, neurological, or psychiatric disorders.
    7. History or presence of malignancy, with the exception of curative treated subject or subject being in remission of cancer for at least 2 years before enrollment and not requiring treatment.
    8. Surgery of any joint within 3 months of the Enrollment Visit or any scheduled surgery or painful procedure during the course of the trial.
    9. Clinically relevant history of hypersensitivity, allergy, or contraindications to any of the IMPs’ drug substances and excipients, or to pantoprazole or paracetamol.
    10. Known hypersensitivity or allergy to lidocaine, other amide anesthetics, or diclofenac.
    11. Conditions that require treatment with forbidden medication.
    12. Painful conditions other than due to OA that contribute relevantly to pain and confound the assessment of self-evaluation of pain, for instance psoriatic arthritis, gout, low back pain, or significant skin conditions such as abscesses.
    13. Known or suspected inability to comply with the requirements of the trial protocol or the instructions of the trial site staff.
    14. Intake of opioids or cannabinoids in the last 3 months before the Enrollment Visit.
    15. Known reactions of bronchospasm, asthma, rhinitis, or urticarial after the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) in the past.
    16. Hematopoietic disorder of unclear genesis.
    17. Persisting or repeatedly occurred peptic ulcers or hemorrhage in the past (at least 2 distinct confirmed episodes of ulceration or bleeding).
    18. Gastrointestinal bleeding or perforation in anamnesis in conjunction with previous therapy with NSAIDs.
    19. Cerebrovascular or other active bleeding.
    20. Severe dysfunction of the liver or kidney.
    21. Known heart insufficiency (New York Heart Association [NYHA] Class II-IV), ischemia of the heart, peripheral artery occlusive disease, and/or cerebrovascular disease.
    22. Skin injuries or open wounds at the site of planned patch application.
    1. Participación en otro ensayo en la actualidad o en el plazo de los 30 días anteriores a la Visita de Reclutamiento para este ensayo. Dependiendo de la naturaleza del medicamento investigado en el ensayo previo, podría precisarse un periodo de lavado mayor.
    2. Evidencia o antecedentes de abuso de alcohol o drogas, lo que incluye un resultado positivo de una prueba de drogas (o la ausencia de su práctica) en la Visita de Reclutamiento.
    3. Mujeres potencialmente fértiles con un resultado positivo de una prueba de embarazo de la gonadotropina coriónica humana β (β-hCG) en orina (o la ausencia de su práctica) en la Visita de Reclutamiento.
    4. Litigio anterior o en curso por dolor o incapacidad de carácter crónico.
    5. Empleados del investigador, del centro del ensayo o del promotor, con intervención directa en el ensayo que se propone o en otros ensayos bajo la dirección de ese investigador, centro del ensayo o promotor, así como familiares del empleado o del investigador.
    6. Toda enfermedad clínicamente importante que, en opinión del investigador, pueda influir sobre las evaluaciones de la eficacia o de la seguridad o afectar a la seguridad del paciente durante su participación en el ensayo, como, por ejemplo, hipertensión no estabilizada o trastornos pulmonares, gastrointestinales (GI), endocrinos, metabólicos, neurológicos o psiquiátricos importantes.
    7. Antecedente o presencia de proceso maligno, salvo si el sujeto ha sido tratado con intención curativa o se encuentra en remisión de la neoplasia desde como mínimo 2 años antes del reclutamiento y no precisa tratamiento.
    8. Cirugía de cualquier articulación en el plazo de los 3 meses anteriores a la Visita de Reclutamiento o cualquier tipo de cirugía o procedimiento doloroso programados durante el curso del ensayo.
    9. Antecedentes clínicamente importantes de hipersensibilidad, alergia o contraindicación a cualquiera de los principios activos o excipientes de los medicamentos en investigación, o al pantoprazol o al paracetamol.
    10. Hipersensibilidad o alergia conocidas a la lidocaína, otros anestésicos de tipo amida o al diclofenaco.
    11. Procesos que precisan tratamiento con un medicamento prohibido (véase la Sección 1.4.3).
    12. Procesos dolorosos de origen distinto a la artrosis que contribuyen de manera considerable al dolor y que pueden confundir la autoevaluación del dolor, por ejemplo, artritis psoriásica, gota, dolor lumbar o procesos cutáneos importantes, como abscesos.
    13. Incapacidad o sospecha de incapacidad para cumplir con los requisitos del protocolo del ensayo o las instrucciones del personal del centro.
    14. Toma de opiáceos o de canabinoides en el plazo de los 3 meses anteriores a la Visita de Reclutamiento.
    15. Reacciones anteriores conocidas de broncoespasmo, asma, rinitis o urticaria tras la toma de ácido acetilsalicílico u otros antiinflamatorios no esteroideos.
    16. Trastorno hematopoyético de origen no claro.
    17. Episodios anteriores persistentes o repetidos de úlcera péptica o hemorragia (al menos 2 episodios distintos confirmados de úlcera o sangrado).
    18. Antecedente de hemorragia o perforación gastrointestinal en ocasión de tratamiento previo con antiinflamatorios no esteroideos.
    19. Hemorragia cerebrovascular o activa de otro tipo.
    20. Insuficiencia hepática o renal importante.
    21. Diagnóstico de insuficiencia cardiaca (Clase II-IV de la New York Heart Association [NYHA]), isquemia miocárdica, enfermedad oclusiva arterial periférica y/o enfermedad cerebrovascular.
    22. Lesión cutánea o herida abierta en el área de la aplicación prevista de los parches.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint which will be compared to placebo is the change from baseline to Week 4 of the double-blind Treatment Period in the weekly average pain intensity.
    La variable principal de evaluación que se comparará con el placebo es el cambio desde el Basal a la Semana 4 del Periodo de Tratamiento en doble ciego en la intensidad del dolor promedio semanal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    Semana 4
    E.5.2Secondary end point(s)
    Change from baseline to Week 4 of the double-blind Treatment Period in the weekly current morning pain intensity on an 11-point NRS.
    Change from baseline to Week 4 of the double-blind Treatment Period in the weekly current evening pain intensity on an 11-point NRS.
    Assessment of responder rate (at least 30% reduction of weekly average pain intensity on an 11-point NRS from baseline to Week 4 of the double-blind Treatment Period and average daily rescue medication intake equal to or below 500 mg paracetamol during Week 4 of the double-blind Treatment Period).
    Change from baseline in pain intensity on an 11-point NRS after physical exercise at the Final Visit.
    Average daily rescue medication intake during Week 4 of the double-blind Treatment Period.
    Cambio desde Basal a la Semana 4 del Periodo de Tratamiento en doble ciego en la intensidad del dolor matutino semanal actual en una NRS de 11 puntos.
    Cambio desde Basal a la Semana 4 del Periodo de Tratamiento en doble ciego en la intensidad del dolor nocturno semanal actual en una NRS de 11 puntos.
    Evaluación de la tasa de respondedores (reducción de como mínimo el 30% en la intensidad del dolor promedio semanal en una NRS de 11 puntos desde el basal a la Semana 4 del Periodo de Tratamiento en doble ciego y toma diaria promedio de medicación de rescate igual a o inferior a 500 mg de paracetamol durante la Semana 4 del Periodo de Tratamiento en doble ciego).
    Cambio desde Basal en la intensidad del dolor en una NRS de 11 puntos tras ejercicio físico en la Visita Final.
    Toma diaria promedio de medicación de rescate durante la Semana 4 del Periodo de Tratamiento en doble ciego.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4
    Semana 4
    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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days11
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 Yes
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    Return to standard of care
    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 Decision2017-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-17
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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