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    Summary
    EudraCT Number:2016-001505-17
    Sponsor's Protocol Code Number:BILA-3716/PRU
    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:2016-06-06
    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 number2016-001505-17
    A.3Full title of the trial
    An exploratory study to evaluate the efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases.
    Estudio exploratorio para evaluar la eficacia y seguridad de bilastina en la reducción del prurito en pacientes con urticaria crónica espontánea y en pacientes con otras enfermedades dermatológicas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reseach study that will evaluate the efficacy and safety of Bilastine in reducing itching in patients with chronic spontaneous urticaria and other skin diseases.
    Estudio de investigación que evaluará la eficacia y seguridad de bilastina en la reducción del picor en pacientes con urticaria crónica espontánea y otras enfermedades dermatológicas.
    A.4.1Sponsor's protocol code numberBILA-3716/PRU
    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 SponsorFAES FARMA, 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 supportFAES FARMA, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLinical
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rosa de Lima, 1-bis. Edificio Alba
    B.5.3.2Town/ cityLas Matas / Madrid
    B.5.3.3Post code28290
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913706000
    B.5.5Fax number+34913726060
    B.5.6E-mailsantiago.zas@linical.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 Yes
    D.2.1.1.1Trade name Bilaxten (for Poland and Spain) Lendin (for Hungary) Ayrinal (for Italy)
    D.2.1.1.2Name of the Marketing Authorisation holderFAES FARMA S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNBILASTINA
    D.3.9.1CAS number 202189-78-4
    D.3.9.2Current sponsor codeF-96221-BM1
    D.3.9.3Other descriptive nameBILASTINA
    D.3.9.4EV Substance CodeSUB37845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Chronic spontaneous urticaria and the following skin disorders:
    1 - Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitisation dermatitis, dyshidrotic eczema, asteatotic eczema, lichen simplex chronicus).
    2 - Prurigo (acute prurigo, subacute prurigo, chronic prurigo).
    3 - Cutaneous pruritus (systemic cutaneous pruritus, local cutaneous pruritus).
    Urticaria crónica espontánea y las enfermedades dermatológicas siguientes.
    1 - Eccema / dermatitis (eccema agudo, eccema crónico, dermatitis de contacto, dermatitis atópica, eccema numular, dermatitis por autosensibilización, eccema dishidrótico, eccema asteatósico, neurodermatitis).
    2 - Prurigo (prurigo agudo, prurigo subagudo, prurigo crónico).
    3 - Prurito cutáneo (prurito cutáneo sistémico, prurito cutáneo local).
    E.1.1.1Medical condition in easily understood language
    The main condition evaluated in this study is pruritus. Urticaria (hives), eczema / dermatitis, prurigo, and cutaneous pruritus are the medical conditions treated in this study.
    La principal indicación evaluada en este estudio es el prurito. Las indicaciones médicas tratadas en este estudio son urticaria (ronchas), eccema / dermatitis, prurigo, y prurito cutáneo.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10012435
    E.1.2Term Dermatitis and eczema
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10037083
    E.1.2Term Prurigo
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10052568
    E.1.2Term Urticaria chronic
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study objective will be to evaluate the efficacy of bilastine in the relief of pruritus in patients with chronic spontaneous urticaria or pruritus associated with other skin diseases.
    El objetivo del estudio será evaluar la eficacia de bilastina en el alivio del prurito en pacientes con urticaria crónica espontánea o prurito asociado con otras enfermedades dermatológicas.
    E.2.2Secondary objectives of the trial
    Secondary objectives will include the assessment of:
    - Efficacy in terms of other symptoms and signs of the disease groups
    - Safety and tolerability of bilastine in terms of adverse events, including ECG and laboratory tests
    - Quality of life.
    Los objetivos secundarios incluirán la evaluación de:
    - La eficacia en términos de otros signos y síntomas de los grupos de enfermedad.
    - La seguridad y tolerabilidad de bilastina en términos de acontecimientos adversos, incluyendo pruebas de laboratorio y electrocardiograma.
    - Calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General inclusion criteria:
    Screening:
    - Patients between 18 and 74 years of age at the time informed consent is obtained who can visit the participating medical institution as outpatients (either male or female).
    - Patients who are able to provide written informed consent by themselves.
    Enrollment:
    - Patients who have not responded to the use of placebo during the run-in period (non-responder is defined as: sum itch/pruritus score first 3 days – sum itch/pruritus score last 3 days <2).
    - Patients will be able to record appropriately on the patient diary during last 3 days before enrollment day and have more than 80% of recording rate of patient diary in run-in period.
    Related-disease inclusion criteria:
    For the group of patients with chronic spontaneous urticaria:
    Screening:
    - Patients with a documented history of chronic spontaneous urticaria for at least 6 weeks prior to consent signature.
    Enrollment:
    - Patients who have at least 4 (maximum score is 9) for sum of the pruritus score of Urticaria Activity Score (UAS) during last 3 days of run-in period, before enrollment day.
    - Patients who have at least 16 (maximum score is 42) for sum UAS during last 7 days (UAS7) before enrollment day.
    For group of patients with eczema / dermatitis, prurigo, or cutaneous pruritus:
    Screening:
    - Patients presenting some of the aforementioned skin diseases.
    - Patients who are thought to be appropriate for the inclusion criteria of the enrollment.
    Enrollment:
    - Patients who have at least 4 (maximum score is 9) for the sum of the Itch Score during last 3 days of run-in period, before enrollment day.
    Criterios generales de inclusión:
    Selección:
    - Pacientes entre 18 y 74 años de edad en el momento de obtener el consentimiento informado que puedan como pacientes ambulatorios acudir al centro del estudio (tanto hombres como mujeres).
    - Pacientes que puedan proporcionar por ellos mismos el consentimiento informado.
    Inclusión:
    - Pacientes que no hayan respondido al uso de placebo durante el periodo de pre-inclusión (se define respondedor como: la suma de la puntuación del picor/prurito de los primeros 3 días – suma de la puntuación de los últimos 3 días es menor (<) 2).
    - Pacientes que registren de manera adecuada el diario durante los últimos 3 días antes del día de la inclusión y que tengan registrado el diario del paciente en el periodo de pre-inclusión en más de un 80%.
    Criterios de inclusión relacionados con la enfermedad:
    Para el grupo de pacientes con urticaria crónica espontánea:
    Selección:
    - Pacientes con historia documentada de urticaria crónica espontánea al menos 6 semanas antes de la firma del consentimiento.
    Inclusión:
    - Pacientes que tengan al menos 4 puntos (la puntuación máxima es 9) en la suma de la puntuación de prurito según la puntuación de la actividad de la urticaria (UAS) durante los últimos 3 días del periodo de pre-inclusión, antes del día de la inclusión.
    - Pacientes que tengan al menos 16 puntos (la puntuación máxima es 42) en la suma de la puntuación de la actividad de la urticaria durante los últimos 7 días (UAS7) antes del día de la inclusión.
    Para el grupo de pacientes con eccema / dermatitis, prurigo, o prurito cutáneo:
    Selección:
    - Pacientes que presenten alguna de las enfermedades dermatológicas previamente mencionadas.
    - Pacientes considerados aptos con respecto a los criterios de inclusión.
    Inclusión:
    - Pacientes que tengan al menos 4 puntos (la puntuación máxima es 9) en la suma de la puntuación de picor durante los últimos 3 días del periodo de pre-inclusión, antes del día de la inclusión.
    E.4Principal exclusion criteria
    The following exclusion criteria apply for all patients:
    Screening:
    S1) Patients with or who have had malignant tumors or patients with severe concomitant diseases including liver disease (liver failure, fulminant hepatitis, cirrhosis, etc.), kidney disease (nephrotic syndrome, acute renal failure, uremia, etc.), thyroid diseases (uncontrolled hyperthyroidism or hypothyroidism), heart disease (congestive cardiac failure, myocardial infarction, sinus tachycardia, atrial fibrillation, atrial flutter, severe arrhythmias, etc.), haematological disease (pancytopenia, leukopenia, etc.), psychiatric/neurological disorders (schizophrenia, dementia, etc.), and autoimmune disease (collagen disorder, etc).
    S2) Patients with previous experience of non-response to antihistamines.
    S3) Patients with fungal, bacterial or viral skin infections (excluding those that do not interfere with the efficacy evaluation).
    S4) Patients with any of the following diseases that may interfere with efficacy evaluation:
     Severe dermographism
     Cholinergic urticaria
     Physical urticaria
     Angiitis or collagen disease induced urticaria
     Paraneoplastic urticaria
     Parasitic urticaria
     Pigmented urticaria
     Schnitzler syndrome
     Cryopyrin associated periodic syndrome (CAPS)
     Psoriasis
    S5) Patients with a history of drug allergy for antihistaminic agents, bilastine or ingredients.
    S6) Pregnant females or nursing mothers, those intending to get pregnant during the study period, those who do not agree to use contraception during the study period and for 4 weeks after completion of administration of the investigational drug, those who do not agree to or cannot undergo a pregnancy test (excluding those who have entered menopause more than a year ago or are medically incapable of getting pregnant) and males who do not agree to use contraception during the study period and for 4 weeks after completion of administration of the investigational drug.
    Enrollment:
    E1) Patients who were treated with the following drugs in the 7 days prior to enrollment day (including topical and non-prescription drugs)
    Antihistamine drugs (including H2 receptor antagonists and common cold remedies containing antihistamine drugs).
    Anti-allergic drugs (thromboxane A2 synthesis inhibitors/receptor antagonists, prostaglandin D2 receptor antagonists, leukotriene receptor antagonists, mediator release inhibitors and Th2 cytokine inhibitors).
    Antiplasmin drugs (tranexamic acid, etc.).
    Glycyrrhizinate.
    Diaminodiphenyl sulfone.
    Antipruritic drugs (pregabalin, crotamiton, etc.).
    E2) Patients who were treated with the following drugs in the 30 days prior to enrollment day:
    Systemic corticosteroids (including depot formulations).
    Tacrolimus hydrate.
    Immunological drugs (methotrexate, cyclophosphamide, mycophenolate mofetil, omalizumab, etc).
    P-glycoprotein (P-gp) inhibitos (ketoconazole, erythromycin, cyclosporine, diltiazem, etc.).
    E3) Patients who were treated with any investigational drug in the 90 days prior to enrollment day (including topical drugs).
    E4) Patients who met any of the screening’s exclusion criteria.
    Los siguientes criterios de exclusión aplican a todos los pacientes:
    Selección:
    S1) Pacientes que tengan o hayan tenido tumores malignos o pacientes con enfermedades concomitantes graves incluyendo enfermedades hepáticas (fallo hepático, hepatitis fulminante, cirrosis, etc.), enfermedades renales (síndrome nefrótico, fallo renal agudo, uremia, etc.), enfermedades tiroideas (hipertiroidismo o hipotiroidismo no controlado), enfermedades cardiacas (fallo cardiaco congestivo, infarto de miocardio, taquicardia sinusal, fibrilación auricular, aleteo auricular, arritmias graves, etc.), enfermedades hematológicas (pancitopenia, leucopenia, etc.), enfermedades psiquiátricas/neurológicas (esquizofrenia, demencia, etc.), y enfermedades autoinmunes (enfermedad vascular del colágeno, etc.).
    S2) Pacientes con experiencia previa de no respuesta a los antihistamínicos.
    S3) Pacientes con infecciones dermatológicas fúngicas, bacterianas, o virales (excluyendo aquellas que no interfieran con la evaluación de eficacia).
    S4) Pacientes con cualquiera de las siguientes enfermedades que puedan interferir en la evaluación de eficacia:
     Demografismo grave
     Urticaria colinérgica
     Urticaria física
     Angeitis o urticaria inducida por enfermedad vascular del colágeno.
     Urticaria paraneoplásica
     Urticaria por parásitos
     Urticaria pigmentosa
     Síndrome Schnitzler
     Síndrome periódico asociado a criopirina (CAPS)
     Psoriasis
    S5) Pacientes con historia de alergia a fármacos con agentes antihistamínicos, bilastina o sus ingredientes.
    S6) Mujeres que estén embarazadas o dando el pecho, mujeres con intención de quedarse embarazadas durante el estudio, mujeres que no consientan usar métodos anticonceptivos durante el estudio y hasta 4 semanas después de la finalización de la administración del fármaco en estudio, mujeres que no quieran o no puedan realizar una prueba de embarazo (excluyendo aquellas que sean menopaúsicas por más de un año o que sean médicamente incapaces de quedarse embarazadas) y hombres que no quieran usar métodos anticonceptivos durante el estudio y hasta 4 semanas después de la finalización de la administración del fármaco en estudio.
    Inclusión:
    E1) Pacientes tratados con los siguientes fármacos 7 días antes del día de la inclusión (incluyendo medicamentos de uso tópico y sin receta)
    Agentes antihistamínicos (incluyendo antagonistas de los receptores H2 y fármacos para tratar el catarro común que contengan agentes antihistamínicos).
    Agentes antialérgicos (antagonistas receptores/inhibidores de la síntesis de tromboxano A2, antagonistas de los receptores de prostaglandina D2, antagonistas de los receptores de los leucotrienos, inhibidores de la liberación de mediadores, e inhibidores de la citoquina Th2).
    Agentes antiplasmáticos (ácido tranexámico, etc.).
    Glicirrizinato.
    Diamino Difenil sulfona.
    Agentes antipruríticos (pregabalina, crotamitón, etc.).
    E2) Pacientes tratados con los siguientes fármacos 30 días antes del día de la inclusión:
    Corticoides sistémicos (incluyendo formulaciones de liberación retardada (depot)).
    Hidrato de Tacrolimus.
    Fármacos inmunológicos (metotrexato, ciclofosfamida, micofenolato mofetil, omalizumab, etc.).
    Inhibidores de la glicoproteína-P (ketoconazo, eritromicina, ciclosporina, diltiazem, etc.).
    E3) Pacientes tratados con algún fármaco en investigación 90 días antes del día de la inclusión (incluyendo fármacos de acción tópica).
    E4) Pacientes que cumplan alguno de los criterios de exclusión de la selección.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable: Mean change in weekly pruritus/itchy severity score from baseline to week 8
    Variable principal de eficacia: Media del cambio semanal en la puntuación de severidad de prurito/picor desde la visita basal a semana 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    The evaluation will be performed after all patients have been included and the database lock has been performed.
    The main population for the analysis will be the Full Analysis Set Population. An additional Per Protocol Population with all the subjects of the Full Analysis Set Population who do not perform any major protocol deviation will serve as complementary analysis for the primary endpoint.
    La evaluación se realizará después de que todos los pacientes hayan sido incluidos y que se haya realizado el cierre de la base de datos.
    La población principal para el análisis será la población completa (FAS). Se realizará un análisis adicional con la población por protocolo (PP), que incluirá a todos los sujetos de la FAS que no tengan ninguna desviación mayor de protocolo, que servirá como análisis complementario de la variable principal.
    E.5.2Secondary end point(s)
    Patients with chronic spontaneous urticaria:
    •Mean change in weekly UAS (UAS7) from baseline to week 1, 2, 4 and 8
    •Mean change in weekly pruritus severity score from baseline to week 1, 2 and 4 (a,b).
    •Mean change in weekly VAS for pruritus from baseline to week 1, 2, 4 and 8 (a,b)
    •Change in daily UAS from baseline (a)
    •Change in daily wheal and itch from baseline (a)
    •Change in daily itch from baseline (a)
    •General improvement factor (reflective) at week 2, 4 and 8
    •Change in DLQI from baseline to week 4 and 8 (c)
    Patients with eczema/dermatitis, prurigo and cutaneous pruritus:
    •Mean change in weekly itch score from baseline to week 1, 2 and 4 (a,b)
    •Mean change in weekly VAS for pruritus from baseline to week 1, 2, 4 and 8 (a,b)
    •Change in daily itch from baseline (a)
    •Change in investigator’s rash score from baseline to week 2, 4 and 8(c)
    •General improvement factor (reflective) at week 2, 4 and 8
    •Change in DLQI from baseline to week 4 and 8(c)

    (a) - Baseline: Mean of each symptom score of enrollment day and 3 days prior to enrollment (mean of total 4 days)
    (b) - Analysis: mean of symptom score at baseline – mean of symptom score for 7 days before each visit.
    (c) - Analysis: Baseline score on Day 0 – score of each visit
    Safety endpoints:
    • Incidence of adverse events (AEs), serious adverse events (SAEs), and related adverse events (rAEs).
    • Change of various clinical laboratory test results, ECG and vital signs.
    Pacientes con urticaria crónica espontánea:
    • Media del cambio semanal en la UAS (UAS7) desde la visita basal a las semanas 1, 2, 4 y 8.
    • Media del cambio semanal en la puntuación de severidad de prurito desde la visita basal a las semanas 1, 2 y 4 (a,b).
    • Media del cambio semanal en la EVA para prurito desde la visita basal a las semanas 1, 2, 4 y 8 (a,b)
    • Cambio diario en la UAS desde la visita basal (a)
    • Cambio diario de los habones y picor desde la visita basal (a)
    • Cambio diario del picor desde la visita basal (a)
    • Factor general de mejora (reflexivo) en las semanas 2, 4 y 8
    • Cambio en el cuestionario de calidad de vida (DLQI) desde la visita basal a las semanas 4 y 8 (c)

    Pacientes con eccema/dermatitis, prurigo y prurito cutáneo:
    • Media del cambio semanal en la puntuación de picor desde la visita basal a las semanas 1, 2 y 4 (a,b)
    • Media del cambio semanal en la EVA para prurito desde la visita basal a las semanas 1, 2, 4 y 8 (a,b)
    • Cambio diario del picor desde la visita basal (a)
    • Cambio en la puntuación de la erupción, a criterio del investigador, desde la visita basal a las semanas, 2, 4 y 8 (c)
    • Factor general de mejora (reflexivo) en las semanas 2, 4 y 8
    • Cambio en el cuestionario de calidad de vida (DLQI) desde la visita basal a las semanas 4 y 8 (c)

    (a) - Visita basal: media de puntuación de cada síntoma el día de la inclusión y 3 días antes de la inclusión (media de un total de 4 días)
    (b) - Análisis: media de la puntuación de síntomas en la visita basal – media de la puntuación de síntomas de los 7 días anteriores a cada visita.
    (c) - Análisis: Puntuación basal en el día 0 – puntuación en cada visita.

    Variables de seguridad:
    - Incidencia de acontecimientos adversos (AAs), acontecimientos adversos graves (AAGs), y acontecimientos adversos relacionados (rAAs).
    - Cambios en los resultados de las pruebas clínicas de laboratorio, ECG y constantes vitales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The evaluation will be performed after all patients have been included and the database lock has been performed.
    La evaluación se realizará después de que todos los pacientes hayan sido incluidos y que se haya realizado el cierre de la base de datos.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Calidad de vida
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) No
    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: 15
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 115
    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 Decision2016-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-30
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