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    Summary
    EudraCT Number:2012-002238-35
    Sponsor's Protocol Code Number:11002X-001
    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:2012-11-12
    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 number2012-002238-35
    A.3Full title of the trial
    A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of an Investigational Eye Drop Formulation with OPTIVE (TM) Unit-Dose for 3 Months in Subjects with Dry Eye Disease
    Estudio multicéntrico, con doble enmascaramiento y aleatorizado para comparar la seguridad y eficacia de una formulación de colirio en investigación con dosis unitarias de OPTIVE (MR) durante 3 meses en sujetos con queratoconjuntivitis seca
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of an Investigational Eye Drop Formulation with OPTIVE (TM) Unit-Dose for 3 Months in Subjects with Dry Eye Disease
    Comparativa de una formulación de colirio en investigación con dosis unitarias de OPTIVE (MR) durante 3 meses en sujetos con queratoconjuntivitis seca
    A.4.1Sponsor's protocol code number11002X-001
    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 SponsorAllergan 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 supportAllergan Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Ltd. EU Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1st Floor Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628494444
    B.5.5Fax number+441628494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 nameEye Drops New Platform Unit-dose (EDNP UD)
    D.3.2Product code 11002X
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARMELLOSE SODIUM
    D.3.9.1CAS number 9004-32-4
    D.3.9.3Other descriptive nameCMC
    D.3.9.4EV Substance CodeSUB01063MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Optava unit dose
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARMELLOSE SODIUM
    D.3.9.1CAS number 9004-32-4
    D.3.9.4EV Substance CodeSUB01063MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dry Eye Disease
    Queratoconjuntivitis seca
    E.1.1.1Medical condition in easily understood language
    Dry Eye Disease
    Queratoconjuntivitis seca
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10013774
    E.1.2Term Dry eye
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and efficacy of Eye Drops New Platform Unit-Dose (EDNP UD) in subjects with signs and symptoms of dry eye disease
    Evaluar la seguridad y la eficacia de dosis unitaria de nueva plataforma de colirio (DU NPC) en sujetos con signos y síntomas de queratoconjuntivitis seca
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, >/= 18 years of age and in good general health
    2.Written informed consent and written documentation in accordance with the relevant country and local privacy requirements have been obtained prior to any study procedures
    3.Have used artificial tears for dry eye
    4.If using RESTASIS® Cyclosporine Ophthalmic Emulsion, must be using drops for >/= 6 months prior to day 1 (baseline)
    5.Women of childbearing potential with a negative pregnancy test result at day 1 (baseline)and who are currently using a reliable form of birth control and agree to use this birth control for the duration of the study
    6.OSDI score of >/=18 and </= 65 (based upon a 0 to 100 scale)
    7.Three consecutive tear break-up time (TBUT) tests of </=10 seconds in at least 1 eye
    8.Corneal and/or conjunctival staining of Grade 1 to 4 (Oxford Scheme, score range = 0 to 5) in at least 1 zone that is related to dry eye in at least 1 eye at day 1 (baseline)
    9.Any systemic medications (over-the-counter, herbal, prescription or nutritional supplements) which may affect dry eye or vision must have a start date of >/=3 months from day 1 (baseline) date and dosage is not expected to change during the study
    10. Subjects with IOP </=20 mm Hg in both eyes. Subjects with primary open angle glaucoma or ocular hypertension (OHT) who are on stable monotherapy bilaterally with both eyes
    IOP controlled (</= 20 mm Hg) may be included. Any topical IOP lowering medications must have a start date of >/=3 months prior to day 1 (baseline) date and dosage is not expected to change during the study. The type of medication will be recorded at baseline as with other concomitant medications
    11.Ability/agreement to continue to wear existing current spectacle correction during the study period (if applicable)
    12.Currently corrected distance visual acuity of at least 6/12 Snellen equivalent in each eye using the 3 meter LogMar chart, with current correction (if necessary)
    13.Ability to follow study instructions and likely to complete all required visits
    1.Hombre o mujer,>/= 18 años y en buen estado de salud general
    2.El consentimiento informado por escrito y la documentación por escrito conforme a los requisitos de privacidad locales aplicables se han obtenido con anterioridad a los procedimientos del estudio
    3.Uso de lágrimas artificiales para la xeroftalmía
    4.Si se utiliza ciclosporina en emulsión oftálmica RESTASIS®, el tratamiento con las gotas debe haber comenzado >/= 6 meses antes del día 1 (momento basal)
    5.Mujeres en edad fértil con un resultado negativo en la prueba de embarazo en el día 1 (momento basal) y que estén utilizando un método anticonceptivo fiable y que consientan en utilizar este método durante el estudio
    6.Puntuación del OSDI >/=18 y </= 65 (según una escala de 0 a 100)
    7.Tres pruebas consecutivas de tiempo de ruptura lagrimal (TRL) </= 10 segundos en al menos un ojo
    8.Tinción corneal o conjuntival de grado 1 a 4 (intervalo de puntuación del esquema de Oxford = 0 a 5) en al menos una zona relacionada con la xeroftalmía, por lo menos en un ojo en el día 1 (momento basal)
    9.Cualquier medicación general (incluidas de venta con y sin receta, herbales o suplementos nutricionales) que pueda afectar a la xeroftalmía o la visión debe tener una fecha de inicio < 3 meses antes del día 1 (momento basal) y no está previsto un cambio de posología durante el estudio
    10.Sujetos con PIO </=20 mm Hg en ambos ojos. Pueden incluirse sujetos con glaucoma primario de ángulo abierto o hipertensión ocular (HTO) que estén sometidos a monoterapia estable bilateral con PIO de ambos ojos controlada (? 20 mm Hg). Cualquier medicamento tópico reductor de la PIO debe tener una fecha de inicio de tratamiento >/= 3 meses antes del día 1 (momento basal) y no está previsto un cambio en la posología durante el estudio. El tipo de medicación se registrará en el momento basal junto con otras medicaciones concomitantes
    11.Capacidad o consentimiento para continuar utilizando la corrección actual existente en las gafas durante el estudio (si procede)
    12.Agudeza visual a distancia corregida actual de al menos 6/12 unidades equivalentes de Snellen en cada ojo con un optotipo LogMar a una distancia de 3 metros, con la corrección actual (si es necesario)
    13.El sujeto es capaz de seguir las instrucciones del estudio y es probable que complete todas las visitas requeridas.
    E.4Principal exclusion criteria
    1.Uncontrolled systemic disease
    2.Known allergy or sensitivity to the study product(s) or its components
    3.Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception
    4.Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study at day 1 (baseline)
    5.Schirmer test (with anesthesia)</=2 mm in either eye at day 1 (baseline)
    6.Anticipated contact lens wear during the study, or subject has worn contact lenses in the last 3 months, prior to day 1 (baseline)
    7.Any scheduled or planned ocular or systemic surgery or procedure during the study which in the investigator opinion may impact the subject study participation
    8.Corneal or conjunctival staining grade of 5 (Oxford Scheme, grade range = 0 to 5) at day 1 (baseline) in any one zone of either eye
    9.The start date of any systemic medication (including over-the-counter, herbal, prescription, or nutritional supplements) which may affect dry eye or vision is < 3 months prior to day 1 (baseline) or a change in dosage is anticipated during the study
    10. Presence of one or more of the following ocular conditions:
    active ocular infection or non-keratoconjunctivitis sicca (KCS) ocular inflammation
    -active ocular allergy
    -history of recurrent herpes keratitis or active disease within 6 months prior to day 1 (baseline)
    -corneal disorder or abnormality that affects corneal sensitivity or normal spreading of the tear film (except superficial punctuate keratitis)
    -severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator, may interfere with the interpretation of the study results
    -KCS secondary to the destruction of conjunctival goblet cells such as occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation
    -substantial non-KCS keratitis with overlying corneal stain or other significant corneal findings not directly related to dry eye. Also, subjects with dry eye signs/symptoms (eg, filamentary keratitis) of a severity where topical monotherapy with an artificial tear would be inappropriate
    11.Occlusion of the lacrimal puncta, for either eye, with punctal plugs or cauterization < 3 months prior to day 1 (baseline)
    12.History of ocular/ophthalmic surgery or trauma which could affect corneal sensitivity and/or tear distribution (eg, cataract surgery, laser-assisted in situ keratomileusis [LASIK], photorefractive keratectomy or any surgery involving a limbal or corneal incision) within 6 months prior to day 1 (baseline)
    13.Subjects cannot enroll if currently using topical ocular medication, or have used topical ocular medication within 2 weeks of enrollment. Exceptions: subjects can be considered who are being bilaterally treated with ONE of the following:
    -monotherapy for glaucoma or OHT using a prostaglandin analog, beta blocker OR Alpha-2 agonist
    -RESTASIS Cyclosporine Ophthalmic Emulsion
    14.Subjects who have discontinued use of RESTASIS Cyclosporine Ophthalmic Emulsion </=3 months prior to day 1 (baseline)
    15.Subjects who have changed the dose of or medication for the treatment of glaucoma or OHT within </= 3 months prior to day 1 (baseline) or a change in dosage is anticipated during the study
    16.Subject has a direct relationship with the investigator or investigational site staff, including but not limited to family members, employees, or students
    17.Subject has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
    1.Enfermedad sistémica no controlada.
    2.Alergia o hipersensibilidad conocidas a los productos del estudio o a sus componentes
    3.Pacientes embarazadas, lactantes, que tengan previsto quedarse embarazadas o en edad fértil y que no utilicen un método anticonceptivo fiable
    4.Participación actual en un estudio de un fármaco o dispositivo en fase de investigación o participación en un estudio de esa naturaleza en los 30 días previos a la entrada en este estudio en el día 1 (momento basal)
    5.Prueba de Schirmer (con anestesia)</=2 mm en cada ojo en el día 1 (momento basal)
    6.Uso previsto de lentes de contacto durante el estudio o el sujeto ha llevado lentes de contacto en los últimos 3 meses, anteriores al día 1 (momento basal)
    7.Cualquier procedimiento o cirugía ocular o general programada o planificada durante el estudio que, en opinión de los investigadores, pueda afectar a la participación del sujeto en el estudio
    8.Tinción corneal o conjuntival de grado 5 (intervalo de puntuación del esquema de Oxford = 0 a 5) en cualquier zona de cualquier ojo en el día 1 (momento basal)
    9.La fecha de inicio de cualquier medicación general (incluidas de venta con y sin receta, herbales o suplementos nutricionales) que pueda afectar a la xeroftalmía o la visión debe ser < 3 meses antes del día 1 (momento basal) o existe un cambio de posología previsto durante el estudio
    10.Presencia de uno o varios de los siguientes trastornos oculares:
    -infección ocular activa o inflamación ocular no debida a queratoconjuntivitis seca (QCS)
    -alergia ocular activa
    -antecedentes de queratitis herpética recurrente o enfermedad activa en los 6 meses previos al día 1 (momento basal)
    -trastorno o anormalidad corneal que afecte a la sensibilidad corneal o al despliegue normal de la película lagrimal (con excepción de la queratitis puntiforme superficial)
    -blefaritis intensa o inflamación evidente del borde palpebral que, ha juicio del investigador, pueda interferir en la interpretación de los resultados del estudio
    -La QCS como consecuencia de la destrucción de células caliciformes conjuntivales como ocurre con el déficit de vitamina A, o bien con la cicatrización como en penfigoide cicatricial, quemaduras por sustancias alcalinas, síndrome de Stevens-Johnson, tracoma o irradiación
    -queratitis apreciable no debida a QCS con tinción corneal superpuesta u otros hallazgos corneales significativos no directamente relacionados con la xeroftalmía. Además, sujetos con signos o síntomas de xeroftalmía (p. ej., queratitis filamentosa) de una intensidad para la que resultaría inapropiada una monoterapia tópica con lágrima artificial
    11.Oclusión de los puntos lagrimales, de cualquier ojo, con tapones lagrimales o cauterización < 3 meses antes del día 1 (momento basal)
    12.Antecedentes de cirugía ocular/oftálmica o trauma que pueda afectar a la sensibilidad de la córnea o la distribución de lágrimas [p. ej., cirugía de cataratas, queratomileusis in situ guiada por láser (LASIK), queratectomía fotorrefractiva o cualquier cirugía que implique una incisión limbal o corneal) en los seis meses anteriores al día 1 (momento basal)
    13.Los sujetos no se pueden incluir si están utilizando actualmente medicación ocular tópica o han utilizado medicación ocular tópica en las dos semanas anteriores a la inclusión. Excepciones: se pueden considerar a aquellos sujetos con UNO de los siguientes tratamientos bilaterales:

    -monoterapia para glaucoma o HTO con análogos de las prostaglandinas, betabloqueantes O BIEN agonistas alfa 2
    -Ciclosporina en emulsión oftálmica RESTASIS
    14.Sujetos que han abandonado el uso de ciclosporina en emulsión oftálmica RESTASIS </=3 meses antes del día 1 (momento basal)
    15.Sujetos que han cambiado la dosis o la medicación para el tratamiento de glaucoma o HTO en los </=3 meses previos al día 1 (momento basal) o existe un cambio de posología previsto durante el estudio
    16.El sujeto tiene relación directa con el investigador o personal del centro de investigación, incluidos pero no limitados a familiares, empleados o estudiantes
    17.El sujeto padece una enfermedad o está en una situación que, en opinión del investigador, puede suponer un riesgo importante para el sujeto, puede generar confusión en los resultados del estudio o puede interferir significativamente con la participación del sujeto en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Measure:
    -Change from baseline in the Ocular Surface Disease Index© (OSDI) Questionnaire Score

    Safety Measures:
    -Adverse Events
    -Biomicroscopy
    -Currently Corrected Distance Visual Acuity
    -Best-corrected Visual Acuity (BCVA)
    -IOP
    Criterio principal de valoración de la eficacia:
    -Cambio respecto al momento basal en la puntuación del cuestionarion del OSDI© (Índice de enfermedad de la superficie ocular).
    Criterios de valoración de la seguridad:
    -Acontecimientos adversos
    -Biomicroscopia
    -Agudeza visual a distancia corregida actualmente
    -MAVC
    -PIO
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    Día 90
    E.5.2Secondary end point(s)
    Secondary Efficacy Measures:
    -Tear Break-up Time (TBUT) (with fluorescein)
    -Corneal staining (Oxford Scheme, with fluorescein)
    -Conjunctival staining (Oxford Scheme, with lissamine green)
    -Schirmer test (with anesthesia)
    Criterios secundarios de valoración de la eficacia:
    -Tiempo de ruptura lagrimal (TRL) (con fluoresceína)
    -Tinción corneal (esquema de Oxford, con fluoresceína)
    -Tinción conjuntival (esquema de Oxford, con verde de lisamina)
    -Prueba de Schirmer (con anestesia)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At visit days 1, 7, 30, 60, 90 or early exit
    Visitas de los días 7, 30, 60 y 90 o salida prematura
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    France
    Germany
    Italy
    Russian Federation
    Spain
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months4
    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 months4
    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: 324
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    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 305
    F.4.2.2In the whole clinical trial 405
    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)
    Standard of Care
    Tratamiento habitual
    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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-07
    P. End of Trial
    P.End of Trial StatusCompleted
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