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    Summary
    EudraCT Number:2015-001534-13
    Sponsor's Protocol Code Number:JAN13004-30
    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:2015-07-10
    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 number2015-001534-13
    A.3Full title of the trial
    Phase IB-II clinical trial of melatonin oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation.
    Ensayo clínico fase IB-II de gel de melatonina oral para la prevención y tratamiento de la mucositis oral en pacientes con cáncer de cabeza y cuello tratados con quimioradioterapia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IB-II clinical trial of melatonin oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation.
    Ensayo clínico fase IB-II de gel de melatonina oral para la prevención y tratamiento de la mucositis oral en pacientes con cáncer de cabeza y cuello tratados con quimioradioterapia.
    A.4.1Sponsor's protocol code numberJAN13004-30
    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 SponsorSPHERIUM BIOMED S.L.
    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 supportSPHERIUM BIOMED S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support S.L.
    B.5.2Functional name of contact pointAnna Colomé
    B.5.3 Address:
    B.5.3.1Street AddressConsell de Cent 334-336 4 planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.6E-mailanna.colome@tfscro.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 nameMelatonin oral gel 3%
    D.3.2Product code JAN13004
    D.3.4Pharmaceutical form Oral gel
    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 INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.2Current sponsor codeJAN13004
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 Yes
    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 placeboOral gel
    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
    Oral mucositis in patients with head and neck cancer undergoing chemoradiation
    Mucositis oral en pacientes con cáncer de cabeza y cuello en tratamiento con quimioradioterapia.
    E.1.1.1Medical condition in easily understood language
    Oral mucositis in patients with head and neck cancer undergoing chemoradiation
    Mucositis oral en pacientes con cáncer de cabeza y cuello en tratamiento con quimioradioterapia.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10037763
    E.1.2Term Radiation mucositis
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of melatonin oral gel 3% mouthwashes compared to placebo in the prevention and treatment of oral mucositis in patients with neck and head cancer undergoing concurrent chemoradiation.
    Evaluar la eficacia de los enjuagues bucales del gel oral de melatonina al 3% en comparación con placebo en la prevención y tratamiento de la mucositis oral en pacientes con cáncer de cabeza y cuello sometidos a quimioradioterapia concurrente.
    E.2.2Secondary objectives of the trial
    -To assess the Quality of Life (QoL) of melatonin oral gel 3% mouthwashes compared to placebo.
    -To evaluate the safety and tolerability of melatonin oral gel 3% mouthwashes in patients with head and neck cancer and oral mucositis secondary to concurrent chemoradiation, compared to placebo.
    -To assess the pharmacokinetic profile of melatonin gel 3% mouthwashes in patients with head and neck cancer and oral mucositis secondary to concurrent chemoradiation.
    -Evaluar la calidad de vida (CV) de los enjuagues bucales con gel oral de melatonina al 3% en comparación con el placebo.
    -Evaluar la seguridad y tolerabilidad de los enjuagues bucales con gel oral de melatonina al 3% en comparación con placebo en pacientes con cáncer de cabeza y cuello y mucositis oral secundaria a la quimioradioterapia concurrente, en comparación con placebo.
    -Evaluar el perfil farmacocinético de los enjuagues bucales con gel oral de melatonina al 3% en pacientes con cáncer de cabeza y cuello y mucositis oral secundaria a la quimioradioterapia concurrente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female patients 18 years or over.
    2.Patients who gave written informed consent.
    3.Life expectancy ? 3 months.
    4.Histologically confirmed diagnosis of non-metastatic TNM-2010 stage III-IV squamous cell carcinoma of the following sites:
    o oral cavity
    o oropharynx or
    o any Head and Neck site with lymph nodes at cervical level II.
    5.Histologically confirmed undifferentiated nasopharyngeal carcinoma.
    6.Patients who have a treatment plan based on systemic treatment (cisplatin or cetuximab) concurrent with radiation with curative intent. Patients may have received up to 3 cycles of neoadjuvant chemotherapy if adverse events related to this treatment are fully resolved before study entry. Patients with a plan of postoperative chemoradiation may be included only if the primary tumour is located in the oral cavity.
    7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
    8.Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
    o Haematology:
    Absolute neutrophil count (ANC) ?1.5 x 109/L
    Haemoglobin ? 10 g/dL
    Platelets ? 100,000 x 109/L
    o Hepatic:
    Total bilirubin ? 2 X (Upper limit normal) ULN
    Alanine amino transferase (ALT) and Asparatate aminotransferase (AST) ?5 x ULN
    o Renal:
    For patients who will receive cisplatin: Serum creatinine ? ULN or, if > ULN calculated creatinine clearance (ClCR) ? 60 mL/min.
    For patients who will receive cetuximab: Serum creatinine <2.0 mg/dl.
    o Nutritional and metabolic:
    Albumin > 3.0 mg/dl
    Magnesium > lower limit normal (LLN) for patients who will receive cetuximab
    1.Hombres y mujeres con edad igual o superior a 18 años.
    2.Pacientes que hayan otorgado su consentimiento informado por escrito.
    3.Esperanza de vida ? 3 meses.
    4.Pacientes que manifiesten su voluntad de cumplir con el tratamiento y el seguimiento
    5.Diagnóstico confirmado histológicamente de carcinoma de células escamosas no metastásico TNM-2010 estadio III-IV en las siguientes localizaciones:
    o cavidad oral
    o orofaringe o
    o cualquier localización de Cabeza y Cuello con nódulos linfáticos a nivel cervical II .
    6.Carcinoma nasofaríngeo indiferenciado confirmado histológicamente.
    7.Pacientes con un plan de tratamiento basado en un tratamiento sistémico (cisplatino o cetuximab) concurrente con radioterapia con intención curativa. Los pacientes pueden haber recibido hasta 3 ciclos de quimioterapia neoadyuvante si los acontecimientos adversos relacionados con este tratamiento están completamente resueltos antes de entrar en el estudio. Los pacientes con un plan de quimiorradioterapia postquirúrgica pueden incluirse únicamente si el tumor primario está localizado en la cavidad oral.
    8.Estado funcional Eastern Cooperative Oncology Group (ECOG) de 0 - 1
    9.Adecuada función orgánica basal (hematológica, hepática, renal, nutricional y metabólica):
    o Hematología:
    Recuento absoluto de neutrófilos ?1.5 x 109/L
    Hemoglobina ? 10 g/dL
    Plaquetas ? 100,000 x 109/L
    o Hepatica:
    Bilirrubina total ? 2 X (Límite superior normal) LSN
    Alanina amino transferasa (ALT) y Asparatato aminotransferasa (AST) ?5 x LSN
    o Renal:
    Para los pacientes que recibirán cisplatino: Creatinina sérica ? LSN o, si > LSN aclaramiento de creatinina calculado ? 60 mL/min.
    Para los pacientes que recibirán cetuximab: Creatinina sérica <2.0 mg/dl.
    o Nutritional y metabólica:
    Albúmina > 3.0 mg/dl
    Magnesio > Límite inferior normal (LIN) para los pacientes que recibirán cetuximab.
    E.4Principal exclusion criteria
    1.Patients with blistering disease.
    2.Patients who require feeding with either nasogastric tube, gastrostomy or jejunostomy at study entry
    3.Patients whose radiotherapy treatment planned dose is lower than 66 Gy
    4.Patients being receiving another investigational agent because of participation in another therapeutic trial
    5.Patients treated with fluvoxamine, estrogens, cimetidine, 5- and 8 methoxypsoralen and/or carbamazepine
    6.Active viral, bacterial or fungal infections of the mouth in the last 14 days (i.e. stomatitis related to herpes virus or candida)
    7.Pregnancy or lactation
    8.Known allergy to melatonin
    9.Prior radiotherapy of the head and neck
    10.Patients with a treatment plan consisting of chemoradiation followed by further chemotherapy
    11.Patients with a diagnostics of a synchronic neoplasia except for non-melanoma skin cancer curable with local treatment or in situ cervix carcinoma
    12.Any investigational agent within 30 days prior to inclusion
    13.Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 2 months after the last administration of the study drug for women and 1 month for men
    14.Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule according to investigator criteria. These conditions should be discussed with the patient before inclusion in the trial.
    1.Pacientes con enfermedad ampollosa .
    2.Pacientes que requieran alimentación mediante sonda nasogástrica, gastrostomía o yeyunostomía en el momento de la inclusión.
    3.Pacientes con un plan de tratamiento radioterápico de dosis inferior a 66 Gy.
    4.Pacientes que estén participando en otro ensayo clínico y estén recibiendo otro producto en investigación.
    5.Pacientes tratados con fluxovamina, estrógenos, cimetidina, 5- y 8?metoxipsoralen y/o carbamacepina.
    6.Infección vírica, bacteriana o fúngica activa en los últimos 14 días localizada en la boca (p.e. estomatitis asociada a herpes virus o cándida).
    7.Embarazo o lactancia.
    8.Alergia conocida a la melatonina.
    9.Tratamiento de radioterapia previo en cabeza y cuello.
    10.Pacientes con un plan de tratamiento consistente en quimiorradioterapia seguido de quimioterapia.
    11.Pacientes con un diagnóstico de neoplasia sincrónica excepto cáncer de piel no-melanoma curable con tratamiento local o carcinoma de cervix in situ.
    12.Cualquier producto en investigación en los 30 días previos a la inclusión.
    13.Hombres y mujeres en edad fértil que no estén de acuerdo en utilizar métodos anticonceptivos adecuados, es decir, métodos anticonceptivos de doble barrera (p.e. diafragma y preservativo) o abstinencia durante el estudio y hasta 2 meses después de la última administración del medicamento en investigación en el caso de mujeres y 1 mes en el caso de hombres.
    14.Cualquier condición psicológica, geográfica, familiar o social que, a criterio del investigador, pueda impedir el cumplimento con el protocolo del estudio y el calendario de visitas. Estas condiciones deben discutirse con el paciente antes de su inclusión en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number (percentage) of patients who develop severe oral mucositis (grade 3-4 according to the RTOG scale).
    Número (porcentaje) de pacientes que desarrollan mucositis oral severa (grado 3-4 según la escala RTOG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening/baseline, 2-3 days before starting radiotherapy or cetuximab, twice a week (in two non-consecutive days) during the 7 weeks of radiation, once a week during the period when patients continue to take IMP (after end of chemoradiotherapy) and at each monthly follow up visit after completion of radiotherapy.
    En la visita de selección/basal, 2-3 días antes del inicio del cetuximab o la radioterapia, 2 veces/semana (en 2 días no consecutivos) durante las 7 semanas de radioterapia, 1 vez/semana durante el periodo en que los pacientes continuan tomando el PEI (tras finalizar la quimioradioterapia) y en cada visita de seguimiento mensual tras el fin de la radioterapia.
    E.5.2Secondary end point(s)
    Efficacy:
    ? Number (percentage) of patients who develop severe oral mucositis (grade 3-4 according to NCI-CTCAE)
    ? Number of days with mucositis of any grade according to the RTOG scale
    ? Number of days with grade 3-4 mucositis according to the RTOG scale
    ? Time to onset of grade 3-4 mucositis according to the RTOG scale from starting systemic antineoplastic treatment
    Quality of Life:
    ? Change from baseline in EORTC QLQ-C30 and EORTC QLQ-H&N35 scores at 4 weeks after radiotherapy start, one week after completion of radiotherapy and at the last follow up visit (three months after completion of radiotherapy).
    ? Change from baseline in ECOG-Performance status score at different time points along the study.
    Safety:
    ? Number (percentage) of patients with grade 1-4 NCI-CTCAE adverse events related to IMP (melatonin oral gel 3%).
    ? Number (percentage) of patients who develop cisplatin or cetuximab-associated grade 1-4 adverse events according to the NCI-CTCAE scale.
    ? Number (percentage) of patients who develop radiation-associated adverse events different from oral mucositis according to the RTOG scale
    Pharmacokinetics:
    Cmax, Tmax, AUC, T1/2, Vd, clearance
    Additional endpoints
    ? Change from baseline in oral pain intensity measured by VAS at different time points along the study.
    ? Number (percentage) of patients who need minor or major opioids
    ? Number (percentage) of patients who need special procedures on nutritional status (feeding tube, jejunostomy, gastrostomy)
    ? Radiotherapy treatment breaks (cause, number of days)
    ? Total dose and intensity of radiotherapy: Total Gy; Gy/week; Gy/day
    ? Milligrams of systemic antineoplastic treatment administered (dose intensity: mg/m2/week)
    ? Number (percentage) of patients with complete response, partial response, stable disease and progression disease using the RECIST 1.1 criteria
    Eficacia:
    ? Número (porcentaje) de pacientes que desarrollan mucositis oral severa (grado 3-4 según NCI-CTCAE)
    ? Número de días con mucositis de cualquier grado según la escala RTOG
    ? Número de días con mucositis grado 3-4 según la escala RTOG
    ? Tiempo entre el inicio del tratamiento antineoplásico sistémico hasta la aparición de mucositis grado 3-4 según la escala RTOG
    Calidad de Vida:
    ? Cambio respecto a basal en las puntuaciones de los cuestionarios EORTC QLQ-C30 y EORTC QLQ-H&N35 a las 4 semanas del inicio de la radioterapia, 1 semana tras la finalización de la radioterapia y en la última visita de seguimiento (3 meses tras la finalización de la radioterapia).
    ? Cambio respecto a basal en la puntuación del estado funcional ECOG l en diferentes puntos de tiempo a lo largo del estudio.
    Seguridad:
    ? Número (porcentaje) de pacientes con acontecimientos adversos grado 1-4 NCI-CTCAE relacionados con el producto en investigación (gel oral de melatonina al 3%).
    ? Número (porcentaje) de pacientes con acontecimientos adversos grado 1-4 NCI-CTCAE relacionados con cisplatino o cetuximab.
    ? Número (porcentaje) de pacientes con acontecimientos adversos relacionados con la radiación diferentes a la mucositis oral según la escala RTOG
    Farmacocinética:
    Cmax, Tmax, AUC, T1/2, Vd, aclaramiento
    Variables adicionales
    ? Cambio respecto al valor basal de la intensidad del dolor oral medido mediante EVA en diferentes puntos de tiempo a lo largo del estudio.
    ? Número (porcentaje) de pacientes que requieren opioides menores o mayores.
    ? Número (porcentaje) de pacientes que requieren procedimientos especiales por su estado nutricional (tubo de alimentación, yeyunostomía, gastrostomía)
    ? Interrupciones del tratamiento radioterápico (causa, número de días)
    ? Dosis total e intensidad de la radioterapia: Gy totales; Gy/semana; Gy/día
    ? Miligramos administrados de tratamiento antineoplásico sistémico (dosis intensidad: mg/m2/semana)
    ? Número (porcentaje) de pacientes con respuesta completa, respuesta parcial, enfermedad estable o progresión de la enfermedad según los criterios RECIST 1.1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mucositis: At screening/baseline, 2-3 days before starting RT or cetuximab, twice a week (2 non-consecutive days) during the 7w of RT, once a week during the period when patients continue to take IMP (after end of QRT) and at each monthly fup visit.
    EORTC QLQ: 2-3 days before starting RT or cetuximab, 4w after RT start, 1w after completion of RT and at last fup visit.
    ECOG PS/VAS: At screening/baseline, 2-3d before starting RT or cetuximab, at day 0 (cetuximab patients), 7, 14, 21,28,35,42, at the end of RT, once a week during the period when patients continue to take IMP and at each monthly fup visit.
    Tumor response:baseline and 2 months after end of RT
    PK: 1st day of treatment,during 7w of RT, after RT completion while patients receive IMP, at last day of IMP treatment
    Mucositis: visita selección/basal, 2-3d antes del inicio del cetuximab o RT, 2 veces/semana (en 2 días no consecutivos) durante las 7 semanas de RT, 1 vez/semana durante el periodo en que los pacientes continuan tomando el PEI (tras finalizar la QRT) y en cada visita de seguimiento mensual tras el fin RT.
    EORTC QL: 2-3d tras inicio RT o cetuximab, 4s tras inicio RT, 1s tras fin RT y en la última visita seguimiento.
    ECOG PS/VAS: visita selección/basal, 2-3d tras inicio RT o cetuximab, día 0 (pacientes cetuximab), 7, 14, 21,28,35,42, al fin de la RT, 1 vez/semana mientras los pacientes siguen con PEI y en las visitas de seguimiento mensuales.
    Respuesta tumoral:basal y 2m tras fin RT
    PK: 1er d tto,durante 7s de RT, tras fin RT mientras reciben PEI, último día tto PEI.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 concerned4
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    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: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state84
    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)
    Normal treatment of that condition
    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 Decision2015-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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