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    Summary
    EudraCT Number:2013-000236-94
    Sponsor's Protocol Code Number:TTD-13-01
    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:2013-04-09
    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 number2013-000236-94
    A.3Full title of the trial
    Phase II study of Regorafenib as a single agent for first-line treatment of patients with metastatic colorectal cancer (MCRC) who are fragile and/or not candidates for polychemotherapy
    Estudio fase II de Regorafenib como agente único para el tratamiento de primera línea de pacientes con Cáncer Colorrectal Metastásico (CCRM) frágiles y/o no candidatos a recibir poliquimioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Regorafenib as a single agent for treatment of patients with metastatic colorectal cancer (MCRC) who are not candidates for polychemotherapy
    Regorafenib como agente único para el tratamiento de pacientes con Cáncer Colorrectal Metastásico (CCRM) no candidatos a recibir poliquimioterapia
    A.3.2Name or abbreviated title of the trial where available
    REFRAME
    A.4.1Sponsor's protocol code numberTTD-13-01
    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 SponsorGrupo de Tratamiento de los Tumores Digestivos (TTD)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo de Tratamiento de los Tumores Digestivos (TTD)
    B.5.2Functional name of contact pointTTD
    B.5.3 Address:
    B.5.3.1Street AddressPlaza de Castilla, 3, 8º D-1
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913788275
    B.5.5Fax number+34913788276
    B.5.6E-mailttd@ttdgroup.org
    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 nameRegorafenib
    D.3.2Product code BAY 73-4506
    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 INNRegorafenib
    D.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor codeBAY 73-4506
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Metastatic colorectal cancer
    Cáncer Colorrectal Metastásico
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    Cancer colorectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10010035
    E.1.2Term Colorectal cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of single-agent regorafenib in terms of progression-free survival at 6 months.
    Evaluar la eficacia de regorafenib como supervivencia libre de progresión a los 6 meses.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of regorafenib.
    - To assess objective response rate,
    - To assess disease control rate,
    - To assess response duration,
    - To assess time to response,
    - To assess time to disease progression,
    - To assess time to treatment failure,
    - To assess duration of stable disease,
    - To assess progression free survival,
    - To assess overall survival.
    - Evaluar la seguridad y tolerabilidad de regorafenib.
    - Evaluar la tasa de respuesta objetiva,
    - Evaluar la tasa de control de la enfermedad,
    - Evaluar la duración de la respuesta,
    - Evaluar el tiempo hasta la respuesta,
    - Evaluar el tiempo hasta la progresión de la enfermedad,
    - Evaluar el tiempo hasta el fracaso del tratamiento,
    - Evaluar la duración de la enfermedad estable,
    - Evaluar la supervivencia libre de progresión,
    - Evaluar la supervivencia global.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biological study to determine potential predictive factors of efficacy
    Estudio biológico para la determinación de posibles factores predictores de eficacia
    E.3Principal inclusion criteria
    1. Signing of the informed consent form.
    2. The patient must be able to understand the information and state expressly his or her desire to take part in the study.
    3. Age > 18 years.
    4. Patients with histologically or cytologically documented adenocarcinoma of the colon or rectum who have not been previously treated systemically for advanced disease. Patients can have received fluoropyrimidine-based adjuvant therapy if the last dose was taken at least 6 months prior to study entry.
    5. Patients who are frail and/or unfit for polychemotherapy owing to the presence of one or more of the following criteria:
    a. Patients with dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease.
    b. Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment:
    - Congestive heart failure
    - Other chronic cardiovascular diseases
    - Chronic obstructive pulmonary disease
    - Cerebrovascular disease
    - Peripheral neuropathy
    - Chronic kidney failure (creatinine clearance >30 mL/min)
    - Hypertension
    - Diabetes mellitus
    - Systemic vasculitis
    - Severe arthritis
    c. Presence of geriatric syndromes such as age > 85 years, faecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly.
    6. Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
    7. Overall Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
    8. Patient's commitment to compliance with the oral medication throughout the duration of the study
    9. Life expectancy of at least 3 months
    10. Adequate bone marrow, renal and hepatic function, defined as:
    a. Neutrophils >1500/mm3
    b. Platelets >100,000/mm3
    c. Haemoglobin ≥ 9,0 g/dL
    d. Creatinine clearance > 30 ml/min
    e. Bilirubin levels < 2.5 x ULN
    f. AST and ALT levels < 3 x ULN (if liver metastases < 5 x ULN)
    1. Firma del consentimiento informado
    2. El paciente debe ser capaz de comprender la información y manifestar expreso deseo de querer participar en el estudio
    3. Edad >18 años
    4. Documentación histológica o citológica de adenocarcinoma de colon o de recto que no haya recibido tratamiento sistémico previo para su enfermedad avanzada. Los pacientes pueden haber recibido tratamiento adyuvante basado en fluoropirimidinas en caso de que la última dosis haya sido recibida al menos 6 meses antes de la entrada en el estudio.
    5. Pacientes frágiles y/o no candidatos a recibir poliquimioterapia debido a la presencia de uno o más de los siguientes criterios:
    a. Dependencia para las actividades de la vida diaria debido a la presencia de comorbilidades diferentes a las del deterioro propio por la enfermedad neoplásica
    b. Presencia en los antecedentes clínicos del paciente de tres o más de las siguientes comorbilidades, aunque se encuentren bajo control por correcto tratamiento;
    -Insuficiencia cardiaca congestiva
    -Otras enfermedades cardiovasculares crónicas
    -Enfermedad pulmonar obstructiva crónica
    -Enfermedad cerebrovascular
    -Neuropatía periférica
    -Insuficiencia renal crónica (aclaramiento de creatinina >30 mL/min)
    -Hipertensión arterial
    -Diabetes mellitus
    -Vasculitis sistémica
    -Artritis severa
    c. Presencia de síndromes geriátricos como: edad > 85 años, incontinencia fecal o urinaria, fracturas espontáneas óseas, demencia de grado leve y moderado o pacientes que presenten caídas de repetición.
    6. Existencia de al menos una lesión unidimensional medible por TAC o RNM de acuerdo a los criterios RECIST versión 1.1
    7. Estado General Eastern Cooperative Oncology Group (ECOG) de grado 2 ó menor
    8. Compromiso del paciente para el cumplimiento de la medicación oral a lo largo de la duración del estudio
    9. Esperanza de vida de al menos 3 meses
    10. Adecuada función medular, renal y hepática definida como:
    a. Neutrófilos >1.500/mm3
    b. Plaquetas > 100.000/mm3
    c. Hemoglobina ≥ 9,0 g/dL
    d. Aclaramiento de creatinina >30 mL/min
    e. Niveles de bilirrubina < 2,5 x LSN
    f. Niveles de ALT o AST <3 x LSN (si metástasis hepáticas < 5 x LSN)
    E.4Principal exclusion criteria
    1. Prior treatment with regorafenib.
    2. Assignment prior to the treatment during this study. Patients who are permanently withdrawn from participation in the study treatment will not be allowed to return to it.
    3. Prior or concurrent presence of another neoplastic disease that is different in terms of tumour site and histology of the colorectal cancer in the 5 years prior to the inclusion of the patient in the study, except in situ cervical cancer, superficial bladder carcinoma [Ta (non-invasive), Tis (carcinoma in situ) and T1 (tumour invades lamina propria)] and non-melanoma skin tumours.
    4. Presence or history of brain metastases or meningeal tumours.
    5. Major surgery, open biopsy or traumatic injury within 28 days prior to the start of patient treatment with the study medication.
    6. Extended-field radiotherapy within 4 weeks prior to randomisation or limited-field radiotherapy in the previous 2 weeks. Patients must have recovered from all treatment-related toxicities.
    7. Pregnant or breast-feeding women. Women of childbearing age must use adequate contraception. Women of childbearing age must have a negative pregnancy test within 7 days prior to starting with the study medication.
    8. Women of childbearing age and men who wish to take part in the study must agree to use adequate contraception from the signing of the informed consent until at least 3 months after stopping the study medication. The investigator or the person designated by him or her will ensure and advise as to the contraceptive methods that should be used.
    Appropriate contraceptive methods include abstinence, oral contraceptives, transdermal patches and injections of sustained-release progestin (starting at least 4 weeks before administration of the IMP), double-barrier method: condom or female condom (diaphragm or cervical/vaginal condom) plus spermicide, intrauterine device (IUD), intrauterine system, implant or vaginal ring (in place at least 4 weeks before administration of the IMP) or male partner sterilisation (vasectomy with documentation of azoospermia) prior to inclusion of the woman in the trial if he is the woman's only sexual partner.
    9. Active congestive heart failure class 2 or higher on the NYHA scale (New York Heart Association).
    10. Unstable angina (angina symptoms at rest), new-onset angina (having appeared in the past 3 months) or acute myocardial infarction that has occurred in the 6 months prior to starting with the study medication.
    11. Cardiac arrhythmias that require anti-arrhythmic therapy (only beta blockers and digoxin would be allowed as concomitant medication for these patients).
    12. Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg) despite proper medical management.
    13. Patients with phaeochromocytoma.
    14. Pleural effusion or ascites that cause breathing difficulties (dyspnoea of grade ? 2 of the CTC).
    15. Venous or arterial thromboembolism or embolic events such as cerebrovascular accidents (including transient ischaemic attacks), deep vein thrombosis or pulmonary thromboembolism that have occurred in the 6 months prior to starting with the study medication.
    16. Active infection > grade 2 based on the NCI CTC, v. 4.0.
    17. Human immunodeficiency virus (HIV) infection.
    18. Active hepatitis B or C, or hepatitis B or C infection that requires treatment with antiviral drugs.
    19. Patients with severe mental disorders that require medication.
    20. History of organ transplants.
    21. Patients with evidence or history of bleeding diathesis. Any bleeding or bleeding event > CTCAE grade 3 in the 4 weeks prior to starting with the study medication.
    22. Presence of unhealed wounds, ulcers or bone fractures.
    23. Kidney failure requiring haemodialysis or peritoneal dialysis.
    24. Dehydration based on NCI CTC criteria, version 4, of > 1.
    25. Substance abuse or a history of medical, social or psychological conditions that may interfere with study participation or compliance with the efficacy and safety assessments planned in the study.
    26. Known hypersensitivity to regorafenib or any of its excipients.
    27. Presence of any disease or medical condition that might interfere with patient safety or may compromise treatment compliance with it.
    28. Interstitial lung disease with signs and symptoms present at the time of signing the informed consent.
    29. Patients who are unable to swallow oral medication.
    30. Persistent proteinuria > grade 3 based on the NCI CTC, version 4.0 (> 3.5 g/24 hours).
    31. Intestinal malabsorption syndrome.
    32. Close personal relationship with the research staff, such as family members of the investigator or dependents (e.g. employees or students of the research centre).
    33. Unresolved toxicity grade > 1 based on the NCI CTC, version 4.0 (except alopecia), related to any previous therapy or procedure.
    1. Tratamiento previo con regorafenib
    2. Asignación previa al tratamiento durante este estudio.
    3. Presencia previa o concurrente de otra enfermedad neoplásica que sea distinta en cuanto al lugar del tumor y la histología del cáncer colorrectal en los 5 años previos a la inclusión del paciente en el estudio excepto cáncer de cérvix in situ, carcinoma superficial de vejiga [Ta (no invasivos), Tis (carcinoma in situ) y T1 (tumor que invade la lámina propia)] y tumores cutáneos no ?melanoma
    4. Presencia o antecedentes de metástasis cerebrales o de tumores meníngeos.
    5. Cirugía mayor, biopsia abierta o herida traumática ocurrida en los 28 días previos al comienzo del tratamiento.
    6. Radioterapia de campo extendido en las 4 semanas previas a la aleatorización o radioterapia de campo limitado en las 2 semanas previas.
    7. Pacientes embarazadas o lactantes. Las mujeres con potencial de embarazo deben emplear métodos anticonceptivos adecuados. Las mujeres con potencial de embarazo deben presentar un test de embarazo negativo.
    8. Las mujeres en edad de posibilidad de embarazo y los hombres que deseen participar en el estudio deben estar de acuerdo en utilizar métodos anticonceptivos adecuados.
    Los métodos anticonceptivos adecuados comprenden abstinencia, anticonceptivos orales, parches transdérmicos e inyecciones de liberación prolongada de un progestágeno (comenzando al menos 4 semanas antes de la administración del IMP), método de doble barrera: condón o preservativo femenino (diafragma o condón cervical/vaginal) más un espermicida, dispositivo intrauterino (DIU), sistema intrauterino, implante o anillo vaginal (colocado al menos 4 semanas antes de la administración del IMP) o esterilización de la pareja masculina (vasectomía con documentación de azoospermia) antes de la inclusión de la mujer en el ensayo si es la única pareja sexual de esa mujer.
    9. Insuficiencia cardiaca congestiva activa de grado superior a 2 según la escala de la NYHA (New York Heart Association)
    10. Angina inestable (síntomas de angina en reposo), angina de reciente comienzo (que haya aparecido en los últimos 3 meses) o infarto agudo de miocardio que haya tenido lugar en los 6 meses previos al inicio del comienzo de la medicación del estudio.
    11. Arritmias cardiacas que requieran tratamiento antiarrítmico (sólo betabloqueantes y digoxina estarían permitidos como medicación concomitante de estos pacientes)
    12. Hipertensión arterial no controlada (presión arterial sistólica > 150 mmHg o presión diastólica > 90 mmHg) a pesar de un correcto manejo médico
    13. Pacientes con feocromocitoma
    14. Derrame pleural o ascitis que provoca dificultades respirotarias (grado de disnea ?2 de los CTC).
    15. Tromboembolismo venoso o arterial o eventos embólicos como accidentes cerebrovasculares (incluyendo episodios isquémicos transitorios), trombosis venosa profunda o tromboembolismo pulmonar que hayan tenido lugar en los últimos 6 meses antes de comenzar la medicación del estudio.
    16. Infección activa > grado 2 de acuerdo a la NCI-CTC v 4.0
    17. Infección por el virus de la inmunodeficiencia humana (VIH)
    18. Hepatitis B o C activa, o hepatitis B o C crónica que requiera tratamiento con antivirales.
    19. Pacientes con alteraciones mentales severas que requieran medicación
    20. Antecedentes de trasplantes de órganos.
    21. Pacientes con evidencia o antecedentes de diátesis hemorrágica. Cualquier hemorragia o evento de sangrado de > CTCAE de grado 3 en las 4 semanas previas al comienzo de la medicación del estudio
    22. Presencia de heridas no cicatrizadas, úlceras o fracturas óseas
    23. Insuficiencia renal que requiera hemodiálisis o diálisis peritoneal.
    24. Deshidratación de acuerdo a los criterios NCI-CTC versión 4 > 1
    25. Abuso de sustancias o antecedentes de condiciones médicas, sociales o psicológicas que puedan interferir en la participación en el estudio o en el cumplimiento de las evaluaciones de eficacia y de seguridad previstos en el estudio
    26. Hipersensibilidad conocida a regorafenib o a cualquiera de sus excipientes
    27. Presencia de cualquier enfermedad o condición médica que pueda dificultar la seguridad del paciente o que pueda comprometer el cumplimiento terapéutico del mismo.
    28. Enfermedad pulmonar intersticial con signos y síntomas presentes en el momento de la firma del consentimiento informado
    29. Pacientes con incapacidad para tragar medicación oral
    30. Proteinuria persistente de > grado 3 según la NCI-CTC versión 4.0 (>3,5 gr/24 horas)
    31. Síndrome de malabsorción intestinal
    32. Relación personal cercana con el personal investigador tales como familiares del investigador o personas dependientes (p.e. empleados o estudiantes del centro investigador)
    33. Toxicidad no resuelta de grado > 1 según la NCI-CTC versión 4.0 (exceptuando alopecia) atribuida a cualquier terapia previa o procedimiento.
    E.5 End points
    E.5.1Primary end point(s)
    6 months progression free survival
    Supervivencia Libre de Progresión a 6 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    Efficacy:
    1- Objective response rate
    2- Disease control rate
    3- Time to response
    4- Time to progression
    5- Progression-free survival
    6- Time to treatment failure
    7- Response duration
    8- Duration of stable disease
    9- Progression free survival
    10- Overall survival
    Safety:
    1- Incidence and severity of AEs (NCI CTC, version 4.0)
    2- Changes in laboratory values
    3- Change in vital signs
    4- Incidence of dose-adjustments and compliance
    5- Incidence of concomitant medication
    6- Changes in ECOG performance status over time from baseline.
    Eficacia:
    1- Tasa de respuesta objetiva
    2- Tasa de control de la enfermedad
    3- Tiempo hasta la respuesta
    4- Tiempo hasta la progresión
    5- Supervivencia Libre de Progresión
    6- Tiempo hasta el fracaso del tratamiento
    7- Duración de la respuesta
    8- Duración de la enfermedad estable
    9- Supervivencia libre de progresión
    10- Supervivencia global
    Seguridad:
    1- Incidencia y gravedad de los AE (NCI CTC versión 4.0)
    2- Cambios en los valores de laboratorio.
    3- Cambio en las constantes vitales
    4- Incidencia de ajustes de dosis y cumplimiento
    5- Incidencia de medicación concomitante
    6- Cambios en el estado funcional ECOG con el tiempo desde la situación basal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Eficacy:
    1- end of treatment
    2- end of treatment
    3- first documented response
    4- end of treatment
    5- end of treatment
    6- end of treatment
    7- end of treatment
    8- end of treatment
    9- progression disease
    10- death
    Safety:
    1- end of treatment
    2- end of treatment
    3- end of treatment
    4- end of treatment
    5- end of treatment
    6- end of treatment
    Eficacia:
    1- fin de tratamiento
    2- fin de tratamiento
    3- primera respuesta documentada
    4- fin de tratamiento
    5- fin de tratamiento
    6- fin de tratamiento
    7- fin de tratamiento
    8- fin de tratamiento
    9- progresión de la enfermedad
    10- fallecimiento
    Seguridad:
    1- fin de tratamiento
    2- fin de tratamiento
    3- fin de tratamiento
    4- fin de tratamiento
    5- fin de tratamiento
    6- fin de tratamiento
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 concerned18
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    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)
    The expected normal treatment of that condition
    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 Decision2013-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
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