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    Summary
    EudraCT Number:2016-001443-39
    Sponsor's Protocol Code Number:167700-004CL
    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:2016-12-27
    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 number2016-001443-39
    A.3Full title of the trial
    A Randomised, Parallel Arm, Placebo-Controlled, Double-Blind, Study of the Safety and Efficacy of PRX167700 Added to Existing Non-steroidal Anti-inflammatory Therapy in Adults with Moderate-to-Severe Knee Pain Due to Osteoarthritis
    Estudio aleatorizado, en doble ciego, de grupos paralelos y controlado con placebo, de la seguridad y la eficacia de PRX167700, añadido al tratamiento ya existente con antiinflamatorios no esteroideos, en adultos con dolor de rodilla de grado moderado a severo por osteoartritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the safety and effect of a drug called PRX167700 on a painful chronic condition, osteoarthritis in the knees
    A.4.1Sponsor's protocol code number167700-004CL
    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 SponsorProximagen Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportProximagen Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProximagen Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressMinerva Building 250, Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223 497 300
    B.5.5Fax number+441223 839 521
    B.5.6E-mailINFO@PROXIMAGEN.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 namePRX167700H
    D.3.2Product code PRX167700
    D.3.4Pharmaceutical form 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 INNPRX167700
    D.3.9.2Current sponsor codePXR167700H
    D.3.9.3Other descriptive namePRX167700
    D.3.9.4EV Substance CodeSUB36484
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboTablet
    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 of the knee
    Osteoartritis de Rodilla
    E.1.1.1Medical condition in easily understood language
    Pain and stiffness in the knee joint
    Dolor y rigidez en la articulacion de la Rodilla
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    •To assess the effect of PRX167700 treatment, on a background of stable oral NSAID therapy, on knee pain, in participants with moderate to severe pain caused by OA
    • Evaluar el efecto del tratamiento con PRX167700, añadido a un tratamiento de fondo estable con AINE orales, sobre el dolor de rodilla en participantes con dolor de grado moderado a severo por OA.
    E.2.2Secondary objectives of the trial
    - To assess the safety of PRX167700 when used in combination with oral NSAIDs.
    - To assess additional measures of efficacy at Day 42 for PRX167700 when used in combination with oral NSAIDs for 6 weeks.
    • Evaluar la seguridad del PRX167700 administrado en combinación con AINE orales.
    • Evaluar, el día 42, otras medidas de la eficacia del PRX167700 administrado en combinación con AINE orales durante 6 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants who have symptomatic primary knee OA for at least 3 months prior to Screening. Participants must have had pain in the target knee for ≥ 14 days per month in the 3 months preceding screening.
    2. A diagnosis of knee OA based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of 2 -3) In the target joint. X-rays taken within the last 12 months may be used for confirmation. One knee should be designated as the target joint. The pain in the target knee joint should exceed the pain experienced in other joints (including the contralateral knee joint and/or ipsilateral hip joint) and pain experienced from any concomitant medical condition.
    3. Stable oral NSAID therapy for the treatment of knee OA for at least 5 of 7 days each week for the 4 weeks preceding the Screening visit (Visit1). Stable therapy is considered to be use of the same dose of the same NSAID for the required number of days each week.
    4. A moderate to severe pain score of ≥ 8 and ≤ 16 in the target knee joint evaluated by the WOMAC Pain Score at the Screening Visit (Visit 1), at the start of the Placebo Run-in (Visit 2), and at Baseline (Visit 3, Day 0).
    5. The same or worse pain at Baseline (Visit 3, Day 0) compared to their WOMAC Pain Score at the start of the Placebo Run-in (Visit 2).
    6. Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive.
    7. Male or female participants between 50 and 75 years of age, inclusive.
    8. Female participants are eligible to participate in the study if they are not of child-bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is postmenopausal as defined in Appendix 5) or, if of child-bearing potential, are not pregnant or lactating, agree to use an highly effective contraception method during the study and have a negative pregnancy test at Screening (Visit 1, serum test from central lab), Visit 2 (urine dipstick method in the clinic), and Baseline (Visit 3, urine dipstick method in the clinic). A highly effective contraception method is defined as:
    a. Established use of oral, injected or implanted hormonal methods of contraception.
    b. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
    c. Sole male partner is vasectomised.
    d. Bilateral tubal occlusion.
    9. Able to provide written informed consent to participate in the study and, in the opinion of the investigator, able to read, comprehend and record information as required by the protocol.
    1.Participantes con osteoartritis (OA) de rodilla primaria sintomática desde al menos 3 meses antes de la selección. Los participantes deben haber presentado dolor en la rodilla de referencia durante ≥14 días al mes en los 3 meses anteriores a la selección.
    2.Diagnóstico de OA de rodilla según los criterios del American College of Rheumatology con confirmación radiológica (grado 2-3 de la escala radiológica de Kellgren-Lawrence) en la articulación de referencia. Para la confirmación podrán emplearse radiografías obtenidas en los últimos 12 meses. Se elegirá una rodilla como articulación de referencia. El dolor de la rodilla de referencia deberá superar al dolor de otras articulaciones (incluidas la rodilla contralateral y la cadera ipsilateral) y al dolor de eventuales procesos médicos concomitantes.
    3.Tratamiento estable con antiinflamatorios no esteroideos (AINE) orales para la OA de rodilla durante un mínimo de 5 días a la semana desde 4 semanas antes de la visita de selección (visita 1). Se considera «tratamiento estable» la administración de la misma dosis del mismo AINE durante el número exigido de días a la semana.
    4.Dolor de grado moderado a severo en la rodilla de referencia con una puntuación de dolor ≥8 y ≤16 en la escala WOMAC (Western Ontario and McMaster Universities Arthritis Index® 3.1), en la visita de selección (visita 1), al comienzo de la preinclusión con placebo (visita 2) y en el momento basal (visita 3, día 0).
    5.Dolor en el momento basal (visita 3, día 0) igual o peor que al comienzo de la preinclusión con placebo (visita 2) según la puntuación de dolor de la escala WOMAC.
    6.Índice de masa corporal (IMC) entre 18 y 40 kg/m2, inclusive.
    Edad y sexo
    7.Varones o mujeres de entre 50 y 75 años de edad, inclusive.
    8.Las mujeres podrán participar en el estudio si no son potencialmente fértiles (es decir, fisiológicamente incapaces de quedarse embarazadas, lo que incluye a las mujeres posmenopáusicas según la definición del apéndice 5) o, en caso de ser potencialmente fértiles, si no están embarazadas ni en periodo de lactancia, se comprometen a utilizar un método anticonceptivo de gran eficacia durante el estudio y presentan un resultado negativo en las prueba de embarazo de la selección (visita 1, prueba en suero en el laboratorio central), la visita 2 (método de tiras reactivas en orina en el centro) y el momento basal (visita 3, método de tiras reactivas en orina en el centro). Los siguientes se consideran métodos anticonceptivos de gran eficacia:
    a.Uso consolidado de anticonceptivos hormonales orales, inyectables o implantables.
    b.Dispositivo intrauterino (DIU) o sistema intrauterino (SIU).
    c.Vasectomía de la única pareja masculina.
    d.Oclusión tubárica bilateral.
    9.Capaz de otorgar el consentimiento informado por escrito para participar en el estudio y, a juicio del investigador, capaz de leer, comprender y registrar la información precisa según el protocolo.
    E.4Principal exclusion criteria
    1.Causes of secondary arthritis of the knee, including septic arthritis, autoimmune joint disease, crystalline diseases, gout, articular fracture, and inherited disorders.
    2. Pain relating to the target joint that has characteristics of neuropathic pain.
    3. Disease of the spine or of lower extremity joints (other than OA) which contribute to the pain in the target joint.
    4. Lower extremity surgery (including arthroscopy) within 6 months prior to Screening (Visit 1) or scheduled for surgery of any kind during the study.
    5. Significant injury to the target joint within 12 months prior to Screening (Visit 1).
    7. Active autoimmune disease or conditions requiring chronic immunosuppressive therapy, including rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, and organ transplant recipient.
    Note: abnormal laboratory values for autoimmunity markers in the absence of other signs and symptoms of autoimmune disease are not exclusionary.
    8. Known history of hypersensitivity or intolerance to paracetamol or NSAIDs.
    9. Known or current history of gastrointestinal bleeding.
    10. Clinically significant illness other than OA within 3 months prior to Screening (Visit 1).
    11. History of malignancy within past 5 years (except for basal cell carcinoma or carcinoma-in-situ of the cervix treated with curative
    intent).
    13. Poorly controlled hypertension at Screening (Visit 1) defined as systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg measured after 5 minutes rest in the supine position. A repeat measure is allowed for the increased blood pressure if judged by the investigator to be white coat syndrome.
    Initiation of anti-hypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on 2 occasions separated by at least one hour. Mean SBP/DBP values must be < 160/100 for eligibility at screening.
    15. Substantial renal dysfunction, defined as creatinine clearance calculated using Cockroft Gault equation < 60 mL/min.
    22. Use of analgesics other than NSAIDs for the treatment of knee OA for at least 25 days out of 30 days preceding the Screening visit (Visit 1).
    This includes, paracetamol, tramadol, opioid-containing preparations, gabapentin, and pregabalin (other preparations may be considered on a case-by-case basis)
    23. For 14 days prior to first dose of study treatment(s) treatment, taking any agent with high risk to prolong the QTc interval or to cause Torsades de Pointes (TdP)
    24. Corticosteroid injections before Screening (Visit 1):
    - Intra-articular into the target joint within 3 months
    -Intra-articular into any site other than the target joint within 1 month
    -Intra-muscular within 3 months
    25. Other therapeutic injections into the target joint within previous 3 months.
    26. Systemic corticosteroids within 1 month of Screening (Visit 1).
    27. Use of any anti-inflammatory biological therapy within 12 months prior to Screening (Visit 1).
    28. Start or change in dosing regimen of other therapies for OA (exclusive of NSAIDs) within 3 months of Screening (Visit 1);
    29. Start or change in an established physiotherapy programme within 2 weeks of Screening (Visit 1).
    32. QTc ≥ 450 msec for males and ≥ 470 msec for females based on an average QTc value of triplicate ECGs evaluated via a central reading facility at Screening Visit 1. This applies to QTc intervals measured by Fridericia's formula. Participants who have ECG abnormalities that preclude reliable assessment of QT are excluded from the study.
    33. ALT, AST or conjugated / direct bilirubin above the upper limit of normal (ULN) at Screening (Visit 1). If ALT and/or AST are no more than 2 x ULN, and bilirubin is normal, these analytes may be re-tested once prior to Visit 2 and, if they fall within normal limits on re-test, the participant may be enrolled. If bilirubin is no more than 1.5 x ULN and
    AST and ALT are within normal limits, bilirubin may be re-tested once prior to Visit 2 and the participant included if the results are within
    normal limits on re-test.
    34. Positive test for hepatitis B or C at screening or participant has known chronic hepatitis B or C.
    35. Any clinical or biological abnormality found at screening (other than those related to OA) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study.
    1.Causas de artritis secundaria de rodilla, tales como artritis séptica, artropatía autoinmunitaria, cristalopatías, gota, fractura articular y trastornos hereditarios.
    2. Dolor relacionado con la articulación de referencia con características de dolor neuropático.
    3.Enfermedad vertebral o de articulaciones de las extremidades inferiores (distinta de la OA) que contribuya al dolor de la articulación de referencia.
    4. Intervención quirúrgica en las extremidades inferiores (incluida la artroscopia) en el plazo de los 6 meses anteriores a la V1 o cualquier tipo de cirugía programada durante el estudio.
    5.Lesión importante en la articulación de referencia en el plazo de los 12 meses anteriores a la V1.
    7.Enfermedad autoinmunitaria activa o procesos que precisen tratamiento prolongado con inmunosupresores, tales como artritis reumatoide, lupus eritematoso sistémico, esclerosis múltiple y trasplante de órgano. En ausencia de otros signos y síntomas, la presencia de valores anormales de marcadores autoinmunitarios en las pruebas analíticas no es motivo de exclusión.
    8.Antecedentes de hipersensibilidad o intolerancia al paracetamol o a los AINE.
    9.Antecedentes o presencia de hemorragia gastrointestinal.
    10.Enfermedad de importancia clínica, aparte de la OA, en el plazo de los 3 meses anteriores a la V1.
    11.Antecedentes de neoplasia maligna en los últimos 5 años (excepto el carcinoma basocelular o el carcinoma de cuello uterino in situ tratados con intención curativa).
    13.Hipertensión arterial mal controlada en la V1, definida como PAS >160 mmHg y/o PAD >100 mmHg determinadas tras 5 min. de reposo en decúbito supino. Se permite repetir la determinación si el investigador considera que es un valor elevado aislado («síndrome de bata blanca»). Se permite el inicio de medicamentos antihipertensivos antes de la entrada en el estudio. Deberá volver a determinarse la presión arterial, con una separación mínima de 1h entre las dos ocasiones. Los valores medios de PAS/PAD deben ser <160/100 mmHg en la selección para poder entrar en el estudio.
    15.Disfunción renal considerable, definida como un aclaramiento de creatinina calculado con la ecuación de Cockroft-Gault <60 ml/min.
    22.Uso de analgésicos distintos de los AINE para el tratamiento de la OA de rodilla durante un mínimo de 25 días a lo largo de los 30 días anteriores a la V1. Los siguientes se consideran analgésicos distintos de los AINE para el tratamiento del dolor por OA: paracetamol, tramadol, preparados con opiáceos, gabapentina y pregabalina (podrían considerarse individualmente otros preparados).
    23.Uso de medicamentos con gran riesgo de prolongar el intervalo QTc o de causar TdP en los 14 días anteriores a la primera dosis del tratamiento del estudio.
    24.Inyecciones de corticosteroides antes de la V1:
    a.Intraarticulares en la articulación de referencia en el plazo de los 3 meses anteriores
    b.Intraarticulares en cualquier otra localización distinta de la articulación de referencia en el plazo del mes anterior
    c.Intramusculares en el plazo de los 3 meses anteriores
    25.Otros tratamientos inyectados en la articulación de referencia en el plazo de los 3 meses anteriores.
    26.Corticosteroides sistémicos en el plazo del mes anterior a la V1.
    27.Productos biológicos antiinflamatorios en el plazo de los 12 meses anteriores a la V1.
    28.Comienzo o modificación de la pauta de tratamiento con otros productos para la OA (excepto AINE) en el plazo de los 3 meses anteriores a la V1
    29.Comienzo o modificación de un programa de fisioterapia consolidado en el plazo de las 2 semanas anteriores a la V1
    32.QTc ≥450 ms en los varones y ≥470 ms en las mujeres, según el valor promedio del QTc en los ECG realizados por triplicado y evaluados por un servicio de lectura centralizada en la V1. Estos intervalos QTc se determinarán con la fórmula de Fridericia. Se excluirá del estudio a los participantes con alteraciones del ECG que no permitan una evaluación fiable del QT.
    33.ALT, AST o bilirrubina conjugada/directa superiores al límite superior de la normalidad (LSN) en el Screening (V1). Si la ALT y/o AST no están por encima de dos veces su LSN, y la bilirrubina es normal, estos parámetros pueden ser nuevamente comprobados una vez antes de la V2 y, si se encuentran dentro de sus límites normales en la nueva prueba, el participante puede ser incluido. Si la bilirrubina no supera 1,5 veces el LSN y la AST y ALT están dentro de sus límites normales, la bilirrubina puede ser nuevamente analizada una vez previamente a la V2 y el participante incluido si los resultados están dentro de sus límites normales en la nueva prueba.
    34.Resultado positivo de las pruebas de hepatitis B o C en la selección o diagnóstico de hepatitis B o C crónica.
    35.Alteración clínica o biológica en la selección (aparte de las relacionadas con la OA) que, en opinión del investigador, revista importancia clínica y no permita participar con garantías en este studio.
    E.5 End points
    E.5.1Primary end point(s)
    •WOMAC Pain Score change from baseline (Day 0) to End of Treatment (Day 42)
    • Variación de la puntuación de dolor de la escala WOMAC entre el momento basal (día 0) y el fin del tratamiento (día 42)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 42
    E.5.2Secondary end point(s)
    •Incidence and severity of treatment emergent adverse events (TEAEs) throughout the dosing period
    •Incidence of TEAEs leading to withdrawal
    •Change in physical examination findings throughout the dosing period
    •Incidence of clinically significant changes on triplicate 12 lead electrocardiograms (ECGs) throughout the dosing period
    •Incidence and severity of treatment emergent changes in laboratory values
    •Change from Baseline in vital signs throughout the dosing period
    •Change from Baseline to Day 42 in the WOMAC Total Score
    •Change from Baseline to Day 42 in the WOMAC Stiffness Score
    •Change from Baseline to Day 42 in the WOMAC Function Score
    •Change from Baseline to Day 42 in the Patient Global Assessment (PGA)
    •Clinical Global Impression of Change (CGI C) at Day 42
    •Proportion of participants with a response at Day 42 as defined by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trial Response Criteria Initiative (OMERACT OARSI) Response Criteria
    •Proportion of participants with a reduction in the WOMAC Pain Score of ≥ 50% at Day 42
    •Withdrawal for lack of efficacy
    •Rescue medication use
    • Incidencia y severidad de los acontecimientos adversos surgidos durante el tratamiento (AAST) a lo largo del periodo de tratamiento
    • Incidencia de los AAST que lleven a la retirada
    • Variación de los hallazgos de la exploración física a lo largo del periodo de tratamiento
    • Incidencia de las alteraciones de importancia clínica en los electrocardiogramas (ECG) de 12 derivaciones realizados por triplicado a lo largo del periodo de tratamiento.
    • Incidencia y severidad de las alteraciones de los valores de laboratorio surgidas durante el tratamiento
    • Variación de las constantes vitales respecto al momento basal a lo largo del periodo de tratamiento
    • Variación de la puntuación total de la escala WOMAC entre el momento basal y el día 42
    • Variación de la puntuación de rigidez de la escala WOMAC entre el momento basal y el día 42
    • Variación de la puntuación de capacidad funcional de la escala WOMAC entre el momento basal y el día 42
    • variación de la valoración global por el paciente (PGA, Patient Global Assessment) entre el momento basal y el día 42
    • Impresión clínica global de cambio (CGI C, Clinical Global Impression of Change) el día 42
    • Porcentaje de participantes con respuesta el día 42 según los criterios de respuesta de Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trial Response Criteria Initiative (OMERACT OARSI)
    • Porcentaje de participantes con una reducción de la puntuación de dolor de la escala WOMAC ≥50% el día 42
    • Retirada por falta de eficacia
    • Uso de medicación de rescate
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, 14, 28, 35 and 42
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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 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 EEA30
    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
    Last visit of the last participant in the study (LVLS)
    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 months0
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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)
    Subjects will resume their usual NSAID/simple analgesic therapy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation MAC Clinical Research
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
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