Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001465-20
    Sponsor's Protocol Code Number:FMLD-ARSIDOS-48
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2021-10-19
    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 number2021-001465-20
    A.3Full title of the trial
    A double-blind, multicenter, randomized clinical trial to assess the efficacy and safety of
    Montelukast in patients with erosive / inflammatory arthrosis of the hands
    Ensayo clínico aleatorizado, multicéntrico, doble ciego para evaluar la eficacia y seguridad de Montelukast en pacientes con artrosis erosiva/inflamatoria de manos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the efficacy and safety of Montelukast in patients with erosive / inflammatory arthrosis of the hands
    Ensayo clínico para evaluar la eficacia y seguridad de Montelukast en pacientes con artrosis erosiva/inflamatoria de manos
    A.4.1Sponsor's protocol code numberFMLD-ARSIDOS-48
    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 SponsorLaboratorios Farmalíder 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 supportLaboratorios Farmalíder S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION S.L
    B.5.2Functional name of contact pointSTART UP UNIT
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rufino González, 14-2º D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491327 50 25
    B.5.5Fax number+3491754 27 21
    B.5.6E-mailstart-up@sermescro.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 nameMontelukast sodium
    D.3.4Pharmaceutical form Capsule, hard
    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 INNMONTELUKAST SODIUM
    D.3.9.1CAS number 151767-02-1
    D.3.9.3Other descriptive nameMONTELUKAST SODIUM
    D.3.9.4EV Substance CodeSUB03324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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
    Erosive / inflammatory arthrosis of the hands
    Artrosis erosiva/inflamatoria de manos
    E.1.1.1Medical condition in easily understood language
    Erosive / inflammatory arthrosis of the hands
    Artrosis erosiva/inflamatoria de manos
    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 10003416
    E.1.2Term Arthrosis
    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
    Assess the analgesic efficacy of Montelukast through the Visual Analog Scale (VAS) after 24 weeks, compared to placebo, in patients with hand erosive arthritis.
    Evaluar la eficacia analgésica de Montelukast mediante la Escala Visual Analógica (EVA) a las 24 semanas, comparado con placebo, en pacientes con artrosis erosiva de mano.
    E.2.2Secondary objectives of the trial
    -Assess the efficacy of Montelukast measured as the increase of the hands’ functionality among the study groups during the treatment period.
    - Assess the changes observed by MRI on the radiological signs of the studied joints (synovitis, bone edema, bone erosions, and flexor tendon tenosynovitis) among the study groups during the treatment period.
    - Know the percentage of rescue medication use and withdrawals during the study.
    - Assess the quality-of-life differences among the study groups.
    - Assess the safety and tolerability of Montelukast.
    - Evaluar la eficacia de Montelukast medida como el incremento de la funcionalidad de manos entre los grupos de estudio durante el periodo de tratamiento.
    - Evaluar los cambios observados por RMN en los signos radiológicos de las articulaciones estudiadas (sinovitis, edema óseo, erosiones óseas y tenosinovitis de tendones flexores) entre los grupos de estudio durante el periodo de tratamiento.
    - Conocer el porcentaje de uso de medicación de rescate y abandonos durante el estudio.
    - Evaluar las diferencias en la calidad de vida entre los grupos de estudio.
    - Evaluar la seguridad y tolerabilidad de Montelukast.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who give their written informed consent and are willing to comply with all the visits and planned procedures required by the study
    2. Patients ≥ 18 years old at the time of the screening visit
    3. Patients with erosive arthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah (Anandarajah, A. 2010) criteria
    4. Patients with a pain ≥ 50 mm in the VAS at the baseline visit
    5. Patients with functional consequence despite the conventional treatment
    1. Pacientes que otorguen su consentimiento informado por escrito y estén dispuestos a cumplir con todas las visitas y los procedimientos programados que requiere el estudio
    2. Pacientes ≥ 18 años en el momento la visita de selección
    3. Pacientes con artrosis erosiva de articulaciones interfalángicas de mano con importante actividad clínica según criterios Anandarajah (Anandarajah, A. 2010)
    4. Pacientes con un dolor en la EVA ≥ 50 mm en la visita basal
    5. Pacientes con repercusión funcional a pesar de tratamiento convencional
    E.4Principal exclusion criteria
    Related to medical history
    1. History of active malignant neoplasm of any type or with a history of malignant neoplasm in the last five years
    2. History of fibromyalgia and/or chronic fatigue syndrome
    3. History of myocardial infarction or stroke, or who have experienced chest pain related to a heart disease, or who have suffered from severe heart disease
    4. History of concurrent rheumatic joint disease (history and/or current presence of signs) that could lead to misinterpretation or interfere with the assessment
    5. Pain in other parts of the body that is more intense than the hand pain and that could interfere with the assessment and the study results.
    6. Patients with poorly controlled AHT (maintained systolic blood pressure >150mm Hg or maintained diastolic blood pressure >95mm Hg)
    7. Patients with poorly controlled diabetes mellitus, defined by a Hemoglobin A1c level >8%
    8. History of immunosuppression
    9. Hepatitis B surface antigen (HBsAg) test result or positive antibody to Hepatitis C
    10. Patients with acute or chronic active infections requiring antimicrobial treatment or severe fungal or viral infections
    11. Patients with a significant coagulation defect
    12. Patients who have been diagnosed with esophageal, gastric, pyloric, or duodenal ulcers, or who have received treatment for them within 30 days prior to the screening visit
    13. Patients with chronic liver disease defined by AST o ALT 2 times upper limit of normal
    14. Patients with chronic kidney disease with blood urea nitrogen (BUN) or serum creatinine levels 2 times the ULN or Clcr<30 ml/minute at the screening visit
    15. History of significant medical conditions, which in the opinion of the investigator, would exclude the patient from participating in this clinical trial

    Related to the investigational medicinal product
    1. Patients taking corticosteroids (oral or injectable), methotrexate, hydroxychloroquine or SYDADOA (slow-acting drugs for the symptomatic treatment of osteoarthritis) in the 12 weeks prior to the screening visit
    2. Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the screening visit
    3. Patients undergoing radioactive synoviorthesis (in the study hand)
    4. Patients who have received any live virus vaccine during the 12 weeks prior to the screening visit (also not allowed during the clinical trial, including 3 months after the last dose of study medication)
    5. Patients under treatment with other disease-modifying antirheumatic biologic drugs
    6. Patients under treatment with oral anticoagulants
    7. Patients under treatment with any other medication that should not be administered due to the risk of adverse interactions with the study medication listed in the protocol
    8. Patients who have used paracetamol or other analgesics and/or NSAIDs during the 15 days prior to the start of study treatment
    9. Patients with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients
    10. Patients with intolerance to study medication due to galactose intolerance, lactase insufficiency or glucose or galactose malabsorption
    11. Patients with a history of known hypersensitivity to sulfonamides
    12. Active peptic ulcer, NSAID gastrointestinal disorders, active gastrointestinal bleeding or history of gastrointestinal bleeding
    13. Patients with a history of asthma, urticaria, acute rhinitis, angioneurotic edema or any other allergic reaction after administration of acetylsalicylic acid or other NSAIDs including COX-2 inhibitors
    14. History of congestive heart failure (NYHA II-IV)
    15. History of ischemic heart disease, peripheral arterial disease and/or established cerebrovascular disease
    16. Crohn's disease or ulcerative colitis

    Related to the study
    1. Pregnant or breastfeeding women
    2. Women of childbearing age and sexually active, who do not agree to take acceptable contraceptive measures during the clinical trial
    3. Patients currently enrolled or who have participated in the 3 months prior to the screening visit in a clinical trial with medicinal products or medical devices
    4. Patients with a scheduled surgery during the clinical trial
    5. History of drug or alcohol abuse during the 12 months prior to the screening visit
    6. Glomerular filtration <60 ml/min/1,73 m2
    7. Patients with any contraindication related to the performance of the MRI test
    Relacionados con antecedentes médicos
    1. Antecedente de neoplasia maligna activa de cualquier tipo o con antecedentes de neoplasia maligna en los últimos cinco años
    2. Antecedente de fibromialgia y/o síndrome de fatiga crónica
    3. Antecedente de infarto de miocardio o ictus, o que hayan experimentado dolor torácico relacionado con una cardiopatía, o que hayan padecido enfermedades cardíacas graves
    4. Antecedente de enfermedades reumáticas articulares concurrentes (antecedente y/o presencia actual de signos) que pudieran dar lugar a una interpretación errónea de la evaluación de la eficacia en el dolor o interfieran en dicha evaluación
    5. Dolor en otra parte del organismo más intenso que el dolor de mano y que pudiera interferir en la evaluación y con los resultados del estudio
    6. Pacientes con HTA mal controlada (presión arterial sistólica mantenida >150mm Hg o presión arterial diastólica mantenida >95mm Hg)
    7. Pacientes con diabetes mellitus mal controlada, definida por un nivel de Hemoglobina A1c>8%
    8. Historia de inmunodepresión
    9. Resultado de prueba del antígeno de superficie de Hepatitis B (HBsAg) o anticuerpo frente Hepatitis C positivo
    10. Pacientes con infecciones agudas o crónicas activas que requieran tratamiento antimicrobiano o infecciones fúngicas o virales graves
    11. Pacientes con un defecto importante de coagulación
    12. Pacientes a los que se han diagnosticado úlcera esofágica, gástrica, del canal pilórico o duodenales, o que hayan recibido tratamiento para ellas en los 30 días previos a la visita de selección
    13. Pacientes con hepatopatía crónica definida por unos niveles de AST o ALT 2 veces superior de la normalidad
    14. Pacientes con nefropatía crónica con unos niveles de nitrógeno ureico en sangre (BUN) o de creatinina sérica 2 veces el LSN o Clcr<30 ml/minuto en la visita de selección
    15. Antecedente de condiciones médicas significativas, que en opinión del investigador excluirían al paciente de participar en este ensayo clínico

    Relacionados con el producto en investigación
    1. Pacientes que tomen corticoesteroides (orales o inyectables), metotrexato, hidroxicloroquina o SYDADOA (Fármacos de acción lenta para el tratamiento sintomático de la artrosis) las 12 semanas previas a la visita de selección
    2. Pacientes que hayan utilizado ácido hialurónico intraarticular (en la mano de estudio) durante las 24 semanas previas a la visita de selección
    3. Pacientes sometidos a sinoviortesis radioactiva (en la mano de estudio)
    4. Pacientes que hayan recibido alguna vacuna de virus vivos durante las 12 semanas previas a la visita de selección (tampoco estarán permitidas durante el ensayo clínico, incluidos los 3 meses posteriores a la última dosis de la medicación de estudio)
    5. Pacientes en tratamiento con otros fármacos biológicos antirreumáticos modificadores de la enfermedad
    6. Pacientes en tratamiento con anticoagulantes orales
    7. Pacientes en tratamiento con algún otro medicamento que no deba administrarse debido al riesgo de interacciones adversas con la medicación del estudio recogidos en el protocolo
    8. Pacientes que hayan utilizado paracetamol u otros analgésicos y/o AINES durante los 15 días previos al inicio del tratamiento del estudio
    9. Pacientes con antecedente de alergia o hipersensibilidad a la medicación del estudio, a la medicación de rescate o a alguno de sus excipientes
    10. Pacientes con intolerancia a la medicación del estudio debido a intolerancia a galactosa, insuficiencia de lactasa o malabsorción de glucosa o galactosa
    11. Pacientes con antecedente de hipersensibilidad a conocida sulfamidas
    12. Úlcera péptica activa, trastornos gastrointestinales por AINES, hemorragia gastrointestinal activa o antecedente de hemorragia gastrointestinal
    13. Pacientes con antecedente de asma, urticaria, rinitis aguda, edema angioneurótico o cualquier otra reacción alérgica después de la administración de ácido acetilsalicílico u otros AlNES, incluyendo inhibidores de la COX-2
    14. Antecedente de insuficiencia cardiaca congestiva (NYHA II-IV)
    15. Antecedente de cardiopatía isquémica, enfermedad arterial periférica y/o enfermedad cerebrovascular establecida
    16. Enfermedad de Crohn o colitis ulcerosa

    Relacionados con el estudio
    1. Mujeres embarazadas o en periodo de lactancia
    2. Mujeres en edad fértil y vida sexual activa, que no accedan a tomar medidas anticonceptivas aceptables durante el ensayo clínico
    3. Pacientes actualmente incluidas o que hayan participado en los 3 meses previos a la visita de selección en un ensayo clínico con medicamentos o productos sanitarios
    4. Pacientes con cirugía programada durante el ensayo clínico
    5. Historia de abuso de drogas o alcohol durante los 12 meses previos a la visita de selección
    6. Filtración glomerular<60 ml/min/1,73 m2
    7. Pacientes con cualquier contraindicación relacionada con la realización de la prueba de RMN
    E.5 End points
    E.5.1Primary end point(s)
    Pain intensity difference in relation to baseline pain (PIDt) after 24 weeks, measured through the Visual Analog Scale (VAS)
    Diferencia de intensidad del dolor con respecto al dolor basal (PIDt) a las 24 semanas, medida a través de la Escala Visual Analógica (EVA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 24 weeks
    Visita Basal and 24 semanas
    E.5.2Secondary end point(s)
    Efficacy assessment
    ▪Assessment of the number of interphalangeal joints with pain on pressure at baseline visit and at weeks 4, 12 and 24.
    ▪Assessment of the number of interphalangeal joints with clinical signs of inflammation at the baseline visit and at weeks 4, 12 and 24.
    ▪Pain intensity (PI) at baseline visit and at weeks 4, 12 and 24.
    ▪Pain intensity difference in relation to baseline pain (PIDt) at weeks 4 and 12.
    ▪VAS scale(0-100mm) of the patient’s stiffness at the baseline visit and at weeks 4, 12 and 24.
    ▪VAS scale(0-100mm) of overall disease activity, by evaluating physician and by patient at baseline visit and at weeks 4, 12 and 24.
    ▪Assessment of the inflammatory activity through MRI at the baseline visit and at week 24.
    ▪AUSCAN hand function scale at baseline visit and at weeks 4, 12 and 24.
    ▪Grasping force using a pressure cuff (previously inflated to 60 mmHg) at the baseline visit and at weeks 4, 12 and 24.
    ▪EuroQol-5d quality-of-life questionnaire at baseline visit and at week 24.
    ▪Amount of patients using rescue medication.
    ▪Biomarker measurement, comparison before and after the 24 weeks of treatment.

    Safety assessment
    ▪ Vital signs (body temperature, heart rate, respiratory rate and blood pressure) and general physical examination
    ▪ Abnormal tests
    ▪ Assessment of adverse events
    Evaluación de eficacia
    ▪ Evaluación del número de articulaciones interfalángicas con dolor a la presión en la visita basal y a las 4, 12 y 24 semanas
    ▪ Evaluación del número de articulaciones interfalángicas con signos clínicos de inflamación en la visita basal y a las 4, 12 y 24 semanas
    ▪ Intensidad de dolor (PI) en la visita basal y a las 4, 12 y 24 semanas
    ▪ Diferencia de intensidad del dolor con respecto al dolor basal (PIDt) a las 4 y 12 semanas
    ▪ Escala EVA(0-100mm) de rigidez del paciente en la visita basal y a las 4, 12 y 24 semanas
    ▪ Escala EVA(0-100mm) de actividad global de la enfermedad, por médico evaluador y por paciente en la visita basal y a las 4, 12 y 24 semanas
    ▪ Evaluación de la actividad inflamatoria mediante RMN en la visita basal y a las 24 semanas
    ▪ Escala funcional de mano AUSCAN en la visita basal y a las 4, 12 y 24 semanas
    ▪ Fuerza de prensión mediante manguito de presión (previamente insuflado a 60 mmHg) en la visita basal y a las 4, 12 y 24 semanas
    ▪ Cuestionario de calidad de vida EuroQol-5d en la visita basal y a las 24 semanas
    ▪ Proporción de pacientes que utiliza medicación de rescate
    ▪ Medición de Biomarcadores, comparación antes y después de las 24 semanas de tratamiento

    Evaluación de Seguridad
    ▪ Constantes vitales (temperatura corporal, frecuencia cardiaca, frecuencia respiratoria y tensión arterial) y exploración física general
    ▪ Alteraciones analíticas
    ▪ Evaluación de Acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy assessment
    ▪ Baseline, 4, 12 and 24 weeks
    ▪ Baseline, 4, 12 and 24 weeks
    ▪ Baseline, 4, 12 and 24 weeks
    ▪ Baseline, 4 and 12 weeks
    ▪ Baseline, 4, 12 and 24 weeks
    ▪ Baseline , 4, 12 and 24 weeks
    ▪ Baseline and 24 weeks
    ▪ Baseline, 4, 12 and 24 weeks
    ▪ Baseline, 4, 12 and 24 weeks
    ▪ Baseline and 24 weeks
    ▪ 4, 12 and 24 weeks
    ▪ Before and after 24 weeks of treatment

    Safety assessment
    ▪ Basaline, 4, 12, 24 weeks and follow up
    ▪ 12 weeks and follow up
    ▪ Basaline, 4, 12, 24 weeks and follow up
    Evaluación de eficacia
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal, 4 y 12 semanas
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal y 24 semanas
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal, a las 4, 12 y 24 semanas
    ▪ Visita basal y 24 semanas
    ▪ 4, 12 y 24 semanas
    ▪ Antes y después de las 24 semanas de tratamiento

    Evaluación de Seguridad
    ▪ Visita basal, a las 4, 12, 24 semanas y seguimiento
    ▪ 12 semanas y seguimiento
    ▪ Visita basal, a las 4, 12, 24 semanas y seguimiento
    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) 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.8.2.4Number 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 concerned15
    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 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
    Última visita del último paciente
    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 months15
    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 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: 196
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state280
    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)
    None
    Ninguno
    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 Decision2022-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-19
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 16 18:33:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA