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    Summary
    EudraCT Number:2016-000998-20
    Sponsor's Protocol Code Number:DRO/IV-2016-ART-02
    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:2016-04-20
    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 number2016-000998-20
    A.3Full title of the trial
    Double-Blind, Randomised, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Chondroitin Sulphate and Glucosamine Hydrochloride in Patients with Hand Osteoarthritis
    Ensayo clínico, doble ciego, aleatorizado, controlado con placebo para evaluar la eficacia y seguridad de la combinación de Condroitín Sulfato e Hidrocloruro de Glucosamina en pacientes afectos de artrosis de mano
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial where the treatment allocation is made randomly. Neither investigator nor patient will know which of the two possible treatments the patient is actually receiving. The aim of the study is to assess the efficacy and safety of the combination of Chondroitin Sulphate and Glucosamine Hydrochloride in Patients with Hand Osteoarthritis
    Ensayo clínico en el que la asignación a uno de los dos tratamientos concretos del estudio se realizará al azar. Ni el investigador ni el paciente sabrán cuál de los dos posibles tratamientos está recibiendo el paciente. El objetivo del estudio es evaluar la eficacia y seguridad de la combinación de Condroitín Sulfato e Hidrocloruro de Glucosamina en pacientes afectos de artrosis de mano
    A.3.2Name or abbreviated title of the trial where available
    PICASSO - PrImary CAre Study with chondroitin Sulphate and glucosamine hydrochloride in Osteoarthrit
    PICASSO - PrImary CAre Study with chondroitin Sulphate and glucosamine hydrochloride in Osteoarthrit
    A.4.1Sponsor's protocol code numberDRO/IV-2016-ART-02
    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 SponsorBIOIBÉRICA 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 supportBIOIBÉRICA S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIOIBÉRICA S.A
    B.5.2Functional name of contact pointMARTA
    B.5.3 Address:
    B.5.3.1Street AddressHERRERO
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934904908
    B.5.5Fax number0034934909 711
    B.5.6E-mailmherrero@bioiberica.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 nameDROGLICAN, granulado para solución oral de 1200 mg/1500 mg
    D.3.4Pharmaceutical form Granules for oral solution
    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 INNDroglican
    D.3.9.3Other descriptive nameGLUCOSAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02354MIG
    D.3.10 Strength
    D.3.10.1Concentration unit d day
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDroglican
    D.3.9.1CAS number 9007-28-7
    D.3.9.3Other descriptive nameCHONDROITIN SULFATE
    D.3.9.4EV Substance CodeSUB13355MIG
    D.3.10 Strength
    D.3.10.1Concentration unit d day
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 placeboGranules for oral solution
    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
    symptomatic hand osteoarthritis
    artrosis sintomática de mano
    E.1.1.1Medical condition in easily understood language
    symptomatic hand osteoarthritis
    artrosis sintomática de mano
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that combination therapy with CS/GH has superior efficacy compared to placebo in pain reduction (average score reduction in Huskisson's 0 to 100 mm Visual Analogue Scale) from baseline to 6 months of treatment in patients with symptomatic hand osteoarthritis
    Demostrar que el tratamiento combinado con CS/HG tiene una efacia superior a placebo en la reducción del dolor (reducción media en la puntuación en la Escala Analógica Visual de Huskisson de 0 a 100 mm) desde el inicio hasta los 6 meses de tratamiento en pacientes con artrosis sintomática de mano
    E.2.2Secondary objectives of the trial
    -Assessment of the Functional Index for Hand Osteoarthritis (FIHOA) score after 6 months of treatment
    -Assessment of the duration of morning stiffness (in minutes)
    -Assessment of the number of joints with pain
    Assessment of the number of joints with swelling
    -Assessment of consumption of rescue medication
    -Patient's global assessment of disease activity and the response to treatment
    -Assessment of health status according to the EuroQoL-5D quality of life questionnaire
    -Assessment of anxiety and depression using the HAD scale.
    -Evaluación de la puntuación del Índice Funcional de Artrosis de Mano (Functional Index for Hand OA - FIHOA) después de 6 meses de tratamiento
    -Evaluación de la duración de la rigidez matinal (en minutos)
    -Evaluación del número de articulaciones con hinchazón (inflamación del tejido blando)
    -Evaluación del consumo de medicación de rescate
    -Evaluación global de la actividad de la enfermedad y de la respuesta al tratamiento por parte del paciente
    -Evaluación del estado de salud según el cuestionario de calidad de vida EuroQoL-5D
    -Evaluación de ansiedad y depresión con la escala HAD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Men and women ? 40 years of age;
    2.Diagnosis of clinical hand osteoarthritis according to ACR criteria (Appendix III);
    3.Patients who have pain and deformities in at least 2 interphalangeal joints of the studied hand;
    4.Patients with simple standard anteroposterior X-ray of both hands obtained within the 6 months prior to screening;
    5.Patients with radiological evidence of hand osteoarthritis grade 2-3 according to the Kellgren-Lawrence radiological scale68. Patients must present radiological involvement of at least 3 interphalangeal joints of the studied hand, with or without rhizarthrosis;
    6.Patients who have had pain in the studied hand most of the days of the month prior to the screening visit;
    7.Patients with hand pain ? 45 mm on Huskisson's Visual Analogue Scale at the screening visit (Appendix IV);
    8.Patients who present a Functional Index of Hand Osteoarthritis (FIHOA) score ? 6 at the secreening visit (Appendix V)55;
    9.Women of childbearing age (women whose last menstrual period was more than one year before study enrolment and those who have had tubal ligation or a hysterectomy performed are excluded) must have obtained a negative result for the pregnancy test conducted in the screening phase and must agree to use a medically acceptable contraceptive method throughout the duration of the study. Men participating in the study must also agree to use a medically acceptable contraceptive if they have intercourse with women of childbearing age;
    10.Patients must have a sufficient level of cognition to allow for proper communication and cooperation with all tests and examinations required in the protocol;
    11.Patients who have been clearly informed of the methods and limitations of the study and agree to sign the informed consent form prior to the conduct of any study procedure and after they;
    12.Patients who are not participating in another clinical trial;
    13.Patients who agree to respect the protocol, attending visits related to the study;
    1.Varones y mujeres con edad ? 40 años;
    2.Diagnóstico clínico de artrosis de mano según los criterios del ACR (American College of Rheumatology) (Anexo III);
    3.Pacientes con dolor y deformidad en al menos 2 articulaciones interfalángicas de la mano en estudio;
    4.Pacientes con radiografía antero-posterior estándar simple de las dos manos obtenida en los 6 meses previos a la inclusión;
    5.Pacientes con evidencia radiológica de artrosis de mano grado 2-3 según la escala radiológica de Kellgren-Lawrence72. Los pacientes deben presentar afectación radiológica por lo menos en 3 articulaciones en ambas manos, con o sin rizartrosis;
    6.Pacientes que hayan presentado dolor la mayoría de los días en el mes previo a la visita de selección en la mano en estudio;
    7.Pacientes con dolor de mano en la Escala Analógica Visual de Huskisson ? 45mm63 en la visita de inclusión (Anexo IV)65;
    8.Pacientes que presenten una puntuación en el Índice Funcional de Artrosis de Manos (FIHOA) ? 663 en la visita de inclusión (Anexo V)63;
    9.Las mujeres en edad fértil (se excluyen de esta definición mujeres cuya fecha de última menstruación sea superior a un año a la visita de selección de este estudio y aquellas a las que se le haya practicado una ligadura de trompas o una histerectomía) deben haber obtenido un resultado negativo en una prueba de embarazo realizada en la fase de selección y deben acceder a utilizar un método anticonceptivo médicamente aceptable mientras dure el estudio. Los hombres participantes en el estudio han de comprometerse también a utilizar un anticonceptivo médicamente aceptable si mantienen relaciones con mujeres en edad fértil;
    10.Pacientes con un nivel cognitivo que permita una adecuada comunicación y cooperación en todas las pruebas y exámenes requeridos en el protocolo;
    11.Pacientes a los que que se les haya informado claramente acerca de los métodos y limitaciones del estudio y que acepten firmar el consentimiento informado antes de la realización de cualquier procedimiento del estudio;
    12.Pacientes que no participen en otro ensayo clínico;
    13.Pacientes que acepten respetar el protocolo, acudiendo a las visitas relacionadas con el estudio;
    E.4Principal exclusion criteria
    1.Patients with isolated unilateral or bilateral rhizarthrosis and/or erosive hand osteoarthritis (having just one erosive joint leads to classifying the patient as erosive).
    2.Patients with a known allergy to CS or GH;
    3.Patients with a seafood allergy;
    4.Patients with a history of intolerance to paracetamol;
    5.Patients with active malignancy of any type or with a history of malignancy in the last five years;
    6.Patients who, in the investigator's judgement, do not have significant clinical alterations in their physical examination and laboratory parameters;
    7.History of any condition which, in the investigator's opinion, could lead to misinterpretation of the study results or could pose an additional risk to the patient;
    8.Concurrent articular rheumatism (history and/or current presence of signs) that could give rise to an erroneous interpretation of the efficacy on pain or which interfere in its assessment, such as carpal tunnel syndrome, Guyon's canal syndrome (involment of cubital nervous), flexor tenosynovitis, trigger finger, chondrocalcinosis, , aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, rheumatoid arthritis, ankilosing spondylitis, psoriasis, inflammatory bowel disease, connective tissue disease, vasculitis, diabetic neuropathy, post-traumatic osteoarthritis of the finger;
    9.Pain in other parts of the body more intense than in the hand, which could interfere with the assessment of the joint index;
    10.Patients with fibromyalgia;
    11.Patients with surgery scheduled during the clinical trial period;
    12.Patients with important diseases or processes, such as psychological or psychiatric disorders or drug consumption which, in the investigator's opinion, is likely to alter the progress of the osteoarthritis or the patient's ability to complete the study;
    13.Patients with poorly controlled diabetes mellitus defined as a level of haemoglobin A1c> 8%69;
    14.Patients with poorly controlled hypertension (sustained systolic blood pressure ?160 mm Hg or sustained diastolic blood pressure ?100 mm Hg)70;
    15.Patients with active acute or chronic infections that require antibiotic treatment, or serious fungal or viral infections (for example, hepatitis, herpes zoster, HIV positive);
    16.Patients with chronic liver or kidney disease, defined by AST or ALT levels > 2 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine levels > 2 times the ULN at the inclusion visit;
    17.Patients with a history of alcohol or drug consumption or abuse in the last 3 years;
    18.Patients who have received any investigationa drug in the 30 days prior to the secreening visit;
    19.Women who are breastfeeding;
    20.Patients who are receiving lithium carbonate, phenytoin or anti-coagulants, such as warfarin (with the exception of ASA up to a maximum daily dose of 100 mg);
    1.Pacientes con rizartrosis aislada unilateral o bilateral y/o exclusivamente que presenten evidencia radiológica de artrosis de mano erosiva (se considerará al paciente afecto de artrosis erosiva de mano si presenta por lo menos una articulación erosiva73,74);
    2.Pacientes con alergia conocida al CS o el HG;
    3.Pacientes con alergia al marisco;
    4.Pacientes con antecedentes de intolerancia al paracetamol;
    5.Pacientes con una neoplasia maligna activa de cualquier tipo o con antecedentes de neoplasia maligna en los últimos cinco años;
    6.Pacientes que, a criterio del investigador, presentan alteraciones clínicas significativas que desaconsejen su participación en el ensayo clínico;
    7.Reumatismos articulares concurrentes (antecedentes y/o presencia actual de signos) que pudieran dar lugar a una interpretación errónea de la evaluación de la eficacia en el dolor o que interfirieran en dicha evaluación, como Síndrome del Tunel Carpiano, Síndrome del Canal de Guyon (afectación del nervio cubital), tenosinovitis palmar, dedo en gatillo, condrocalcinosis, osteonecrosis aséptica, gota, artritis séptica, ocronosis, acromegalia, hemocromatosis, enfermedad de Wilson, osteocondromatosis, artritis reumatoide, espondilitis anquilosante, psoriasis, enfermedad inflamatoria intestinal, enfermedades del tejido conectivo, vasculitis, neuropatía diabética, artrosis de dedo postraumatismo;
    8.Dolor en otras partes del organismo más intenso que el dolor de mano y que pudiera interferir en la evaluación de la articulación índice;
    9.Pacientes con fibromialgia;
    10.Pacientes con cirugía programada durante el periodo del ensayo;
    11.Pacientes con enfermedades o procesos de importancia, tales como trastornos psicológicos o psiquiátricos o consumo de drogas que, en opinión del investigador, es probable que alteren la evolución de la artrosis o la capacidad del paciente para completar el estudio;
    12.Pacientes con diabetes mellitus mal controlada, definida por un nivel de hemoglobina A1c> 8%75;
    13.Pacientes con hipertensión mal controlada (presión arterial sistólica mantenida ?160 mm Hg o presión arterial diastólica mantenida ?100 mm Hg)76;
    14.Pacientes con infecciones agudas o crónicas activas que requieran tratamiento antimicrobiano, o infecciones fúngicas o virales (por ejemplo, hepatitis, herpes zóster, positivo para el VIH) graves;
    15.Pacientes con hepatopatía o nefropatía crónicas, definidas por unos niveles de AST o ALT>2 veces el límite superior de la normalidad (LSN) o unos niveles de nitrógenos ureico en sangre (BUN) o de creatinina sérica>2 veces el LSN, en la visita de inclusión;
    16.Pacientes con antecedentes de abuso de consumo de alcohol o de drogas en los últimos 3 años;
    17.Pacientes que hayan recibido cualquier fármaco de investigación en los 30 días previos a la visita de selección;
    18.Mujeres en periodo de lactancia;
    20.Pacientes que estén recibiendo carbonato de litio, fenitoína o anticoagulantes, por ejemplo, warfarina (con excepción de ácido acetilsalicílico hasta una dosis diaria máxima de 100 mg);
    E.5 End points
    E.5.1Primary end point(s)
    -Change since the start of the study in spontaneous pain (average reduction in the scoring of Huskisson's 0-100 mm Visual Analogue Scale) after 6 months of treatment in the studied hand between treatments.
    -Cambio desde el inicio del estudio del dolor espontáneo (reducción media en la puntuación en la Escala Analógica Visual de Huskisson 0-100 mm) después de 6 meses de tratamiento en la mano estudiada entre los grupos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 monts
    6 meses
    E.5.2Secondary end point(s)
    1-Assessment of the Functional Index for Hand Osteoarthritis (FIHOA).
    2-Assessment of Grip Strength.
    3-Count of the number of joints with pain.
    4-Count of the number of joints with swelling.
    5-Duration of morning stiffness (in minutes).
    6-Consumption of the rescue drug.
    7-Patient's global assessment of disease activity.
    8-Patient's global assessment of response to treatment.
    9-Health status according to the EuroQoL-5D quality of life questionnaire.
    10-Assessment of anxiety and depression using the HAD scale.
    1-Evaluación de la funcionalidad según el Índice Funcional de Artrosis de Mano (Functional Index for Hand OA - FIHOA).
    2-Evaluación de la fuerza de prensión.
    3-Recuento del número de articulaciones con dolor.
    4-Recuento del número de articulaciones inflamadas.
    5-Duración de la rigidez matinal.
    6-Consumo de medicación de rescate.
    7-Evaluación global de la actividad de la enfermedad por parte del paciente.
    8-Evaluación global de la respuesta al tratamiento por parte del paciente.
    9-Evaluación del estado de salud según el cuestionario de calidad de vida EuroQoL-5D.
    10-Evaluación de la presencia de ansiedad y depresión mediante la escala HAD (Hospital Anxiety and Depression scale - HAD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: after 6 months
    2: day 0, 30, 60, 120 y 180.
    3: Selection visit, day 0, 30, 60, 120 y 180.
    4: Selección, día 0, 30, 60, 120 y 180.
    5: day 0, 30, 60, 120 y 180.
    6: day 0, 30, 60, 120 y 180.
    7: day 0, 30, 60, 120 y 180.
    8: day 30, 60, 120 y 180
    9: day 0, 30, 60, 120 y 180.
    10: day 0, 30, 60, 120 y 180.
    1: a los 6 meses
    2: día 0, 30,60, 120 y 180.
    3: Selección, día 0, 30,60, 120 y 180.
    4: Selección, día 0, 30,60, 120 y 180.
    5: día 0, 30, 60, 120 y 180.
    6: día 0, 30, 60, 120 y 180.
    7: día 0, 30, 60, 120 y 180.
    8: día 30, 60, 120 y 180
    9: día 0, 30, 60, 120 y 180.
    10: día 0, 30, 60, 120 y 180.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned7
    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: 30 days after the last dose of the investigational medicinal product for the last patient included. Treatment period 6 months
    LVLS: 30 días después de la última dosis del producto en investigación para el último paciente inlcuido. El periodo de tratamiento es de 6 meses.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 330
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state34
    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 Decision2016-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
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