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    Summary
    EudraCT Number:2014-003972-21
    Sponsor's Protocol Code Number:DS5565-A-U307
    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:2015-07-31
    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 number2014-003972-21
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED SAFETY STUDY OF DS-5565 FOR TREATMENT OF PAIN DUE TO FIBROMYALGIA IN SUBJECTS WITH CHRONIC KIDNEY DISEASE
    Estudio de seguridad aleatorizado, doble ciego, controlado con placebo de DS-5565 para el tratamiento del dolor debido a fibromialgia en sujetos con enfermedad renal crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial which compares the safety of a not yet approved drug called DS-5565 versus placebo, in patients with pain related to fibromyalgia who also suffer from chronic kidney disease
    Ensayo clínico que compara la seguridad de un fármaco aún no aprobado llamado DS-5565 con placebo, en pacientes con dolor debido a fibromialgia que también padecen de enfermedad renal crónica
    A.4.1Sponsor's protocol code numberDS5565-A-U307
    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 SponsorDaiichi Sankyo Development 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 supportDaiichi Sankyo Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Application
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34917088600
    B.5.5Fax number441753482800
    B.5.6E-maileuregaffairs@dsd-eu.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 nameDS-5565
    D.3.2Product code DS-5565
    D.3.4Pharmaceutical form Film-coated 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 INNMirogabalin
    D.3.9.2Current sponsor codeDS-5565
    D.3.9.3Other descriptive nameDS-5565
    D.3.9.4EV Substance CodeSUB60040
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboFilm-coated tablet
    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
    DS-5565 is being investigated for the treatment of pain associated with fibromyalgia (FM) in subjects with chronic kidney disease.
    DS-5565 está siendo investigado para el tratamiento del dolor asociado a fibromialgia (FM) en sujetos con enfermedad renal crónica
    E.1.1.1Medical condition in easily understood language
    Treatment of pain related to fibromyalgia in patients with kidney disease.
    Tratamiento del dolor asociado a fibromialgia en pacientes con enfermedad renal
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of subjects with FM and moderate to severe renal dysfunction during 13 weeks of renally adjusted dosing of DS-5565 compared to placebo.
    Determinar la seguridad y la tolerabilidad en sujetos con FM y disfunción renal de moderada a grave durante 13 semanas con una dosis ajustada renalmente de DS-5565 en comparación con placebo
    E.2.2Secondary objectives of the trial
    ? To compare change in weekly average pain as assessed by average daily pain score (ADPS) from baseline measured at randomization to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes the worst pain over the previous 24 hours
    ?To assess the effects of DS-5565 on patient global impression of change (PGIC) at Week 13/ET.
    ? Comparar semanalmente el cambio en el dolor medio según la evaluación de la puntuación media diaria del dolor (average daily pain score, ADPS) partiendo de los valores iniciales medidos en la aleatorización hasta la semana 13 en sujetos que reciben dosis de DS-5565 en comparación con placebo. La ADPS semanal se basa en las puntuaciones diarias del dolor indicadas por el sujeto que mejor describan el peor dolor durante las 24 horas previas
    ? Evaluar los efectos de DS-5565 en la impresión global del paciente sobre los cambios (patient global impression of change, PGIC) en la semana 13/RT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ? 18 years
    2. Able to give written informed consent
    3. Able to complete patient-reported questionnaires per the Investigator's judgment
    4. Estimated CrCl between 15-59 mL/min from serum creatinine by the central laboratory using the Cockcroft-Gault equation
    5. Fibromyalgia meeting American College of Rheumatology criteria for FM:
    a. Widespread pain index (WPI) ? 7 and symptom severity (SS) scale score ? 5, or WPI 3 to 6 and SS scale score ? 9,
    b. Pain in at least 11 of 18 specific tender point sites,
    c. Symptoms have been present at a similar level for at least 3 months, and
    d. The subject does not have a disorder that would otherwise explain the pain
    6. ADPS of ? 4 on the 11-point numeric rating scale (NRS) over the 7 days prior to randomization (based on completion of at least 4 daily pain assessments during the 7-day baseline period prior to randomization)
    7. Women of child bearing potential (WOCBP) must be using adequate methods of contraception (as detailed in Section 4.1.3) to avoid pregnancy during the study and for 4 weeks after study completion.
    1. Edad ?18 años.
    2. Capacidad para dar el consentimiento informado por escrito.
    3. Capacidad para completar cuestionarios notificados por el paciente a juicio del investigador.
    4. AcCr calculado entre 15-59 ml/min a partir de la creatinina sérica por el laboratorio central utilizando la ecuación de Cockcroft-Gault.
    5. Fibromialgia que cumpla con los criterios del Colegio Americano de Reumatología (American College of Rheumatology) para FM:
    a. Índice de dolor generalizado (widespread pain index, WPI) ?7 y puntuación en la escala de gravedad de los síntomas (sympton severity, SS) ?5, o WPI entre 3 y 6 y puntuación en la escala de SS ?9.
    b. Dolor en al menos 11 de los 18 sitios de puntos sensibles
    c. Los síntomas han estado presentes en un nivel similar durante al menos 3 meses.
    d. El sujeto no tiene un trastorno que, de otro modo, explicaría el dolor.
    6. ADPS de ?4 en la escala de clasificación numérica (numeric rating scale, NRS) de 11 puntos durante los últimos 7 días previos a la aleatorización (basada en la cumplimentación de al menos 4 evaluaciones de dolor cada día durante el periodo inicial de 7 días previo a la aleatorización).
    7. Las mujeres en edad fértil (MEF) deben estar utilizando un método anticonceptivo adecuado (según se detalla en la Sección 4.1.3) con el fin de evitar quedarse embarazadas durante el estudio y durante 4 semanas después de la finalización del estudio.
    E.4Principal exclusion criteria
    1. Need for ongoing use of concomitant chronic pain medications or any new non-pharmacological pain management techniques that may confound assessments of efficacy and/or safety, including neurolytic treatments (destruction of nerves by chemicals, heat, cold) or surgery, intrathecal pumps, spinal cord stimulators or psychological support
    within the previous year. Also excluded: topical capsaicin within 6 months; or systemic corticosteroids within 3 months of baseline period.
    2. Unable to undergo pre-study washout of prohibited concomitant medications
    3. Subjects with recent history (i.e., within 1 year prior to screening) of alcohol abuse or illicit drug use (cocaine, heroin, marijuana [including medical, prescribed], etc.)
    4. Use of any selective serotonin reuptake inhibitor (SSRI), unless the subject has been on a stable dose
    for ? 90 days prior to screening and is not anticipated to need any dose adjustment during the course of the study
    5. Subjects with severe or uncontrolled depression that, in the judgment of the Investigator, makes the subject inappropriate for entry into the study
    6. Significant neurological or psychiatric disorder unrelated to neuropathic pain
    7. Other severe pain (eg, sciatica, rheumatoid arthritis) that might impair the assessment of neuropathic
    pain
    8. CrCl ? 60 mL/min estimated from serum creatinine by the central laboratory using the Cockcroft-Gault
    equation.
    9. Subjects who are on hemodialysis or who require hemodialysis before the follow-up assessment;
    acute renal failure; history of kidney transplant
    10. Any history of a malignancy other than basal cell carcinoma within the past 5 years
    11. Clinically significant unstable neurologic, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (eg, severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) within 12 months prior to screening
    12. Pregnancy or breast feeding or intent to become pregnant during the study period
    13. Known hypersensitivity to ?2? ligands or other components of the study medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity to DS-5565 was not observed.
    14. Clinically significant ECG abnormalities at the Screening Visit
    15. Subjects who are at risk of suicide, as defined by their responses to the C-SSRS or in the opinion of the Investigator. Note: Subjects answering "yes" to any of the questions about active suicidal ideation/intent/behaviors that occurred within the past 12 months must be excluded (C-SSRS Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section - any of the suicide behaviors questions). Such subjects should be referred immediately to a mental health professional for appropriate evaluation.
    16. Subjects who are unlikely to comply with the protocol (eg, uncooperative attitude, inability to return for subsequent visits, and/or otherwise considered by the Investigator to be unlikely to complete the study)
    17. Subject is currently enrolled in, or it has been fewer than 30 days since ending, another investigational device or drug study or is receiving another investigational agent.
    18. Subjects who are employees or immediate family of employees of the study site, Sponsor, or contract research organization (CRO)
    19. Screening laboratory values outside the limits listed in the protocol
    1. Necesidad de uso continuado de medicamentos simultáneos para el dolor crónico o cualquier nueva técnica no farmacológica para el tratamiento del dolor que pueda confundir la evaluación de la eficacia o la seguridad, incluidos tratamientos neurolíticos (destrucción de nervios mediante sustancias químicas, calor o frío) o cirugía, bombas intratecales, estimuladores de la médula espinal o apoyo psicológico durante el año previo. También se excluyen: capsaicina tópica en los 6 meses anteriores o corticoesteroides sistémicos en los 3 meses anteriores al periodo inicial.
    2. Imposibilidad de someterse al reposo farmacológico de medicamentos simultáneos prohibidos previo al estudio
    3. Sujetos con antecedentes recientes (esto es, en el periodo de 1 año previo a la selección) de alcoholismo o consumo ilícito de drogas (cocaína, heroína, marihuana [lo que incluye la recomendación médica o prescripción], etc.).
    4. Uso de cualquier inhibidor selectivo de la recaptación de la serotonina (selective serotonin reuptake inhibitor, SSRI), a menos que el sujeto haya estado recibiendo una dosis estable durante ?90 días antes de la selección y no se prevé que necesite ningún tipo de ajuste de la dosis en el curso del estudio.
    5. Sujetos con depresión grave o no controlada que, a juicio del investigador, haga inadecuado el ingreso de los sujetos en el estudio.
    6. Trastornos neurológicos o psiquiátricos significativos no relacionados con el dolor neuropático.
    7. Otro dolor grave (p. ej., ciática, artritis reumatoide) que pudiera afectar a la evaluación del dolor neuropático.
    8. AcCr ?60 ml/min calculado a partir de la creatinina sérica por el laboratorio central utilizando la ecuación de Cockcroft-Gault.
    9. Sujetos sometidos a hemodiálisis o que necesiten hemodiálisis antes de la evaluación de seguimiento; insuficiencia renal aguda; antecedentes de trasplante de riñón.
    10. Cualquier antecedente de neoplasia maligna distinto de carcinoma basocelular dentro de los últimos 5 años.
    11. Enfermedades neurológicas, oftalmológicas, hepatobiliares, respiratorias o hematológicas inestables de importancia clínica o enfermedad cardiovascular inestable (p. ej., hipotensión grave, arritmia cardiaca no controlada o infarto de miocardio) dentro de los 12 meses previos a la selección.
    12. Embarazo o lactancia, o intención de quedarse embarazada durante el periodo del estudio.
    13. Hipersensibilidad conocida a ligandos ?2? o a otros componentes de los medicamentos del estudio. Nota: se permite la exposición previa a DS-5565, siempre y cuando no se observara hipersensibilidad al mismo.
    14. Anomalías de importancia clínica en el ECG en la visita de selección.
    15. Sujetos que tengan riesgo de cometer suicidio según se define por sus respuestas en la escala de Columbia de clasificación de intensidad de las ideas suicidas (Columbia-Suicide Severity Rating Scale, C-SSRS) o en opinión del investigador. Nota: los sujetos que respondan ?sí? a alguna de las preguntas sobre pensamientos/intenciones/comportamientos suicidas activos dentro de los últimos 12 meses deben quedar excluidos (sección de pensamientos suicidas de la C-SSRS: preguntas 3, 4 o 5; sección de comportamiento suicida de la C-SSRS, cualquiera de las preguntas sobre comportamiento suicida). Se debe derivar a estos sujetos inmediatamente a un profesional de la salud mental para una evaluación apropiada.
    16. Sujetos que probablemente no cumplirán con el protocolo (p. ej., debido a una actitud poco cooperativa, a la imposibilidad de regresar para visitas posteriores o debido a que el investigador considere que probablemente no completarán el estudio por otro motivo).
    17. El sujeto está actualmente inscrito en otro estudio de un dispositivo o fármaco en fase de investigación, o han transcurrido menos de 30 días desde la conclusión de este, o está recibiendo otros fármacos en fase de investigación.
    18. Sujetos que sean empleados o familia inmediata de empleados del centro del estudio, del promotor o de la organización de investigación contratada (contract research organization, CRO).
    19. Valores analíticos de selección fuera de los límites recogidos en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety objective is the safety and tolerability of renally adjusted doses of DS-5565 versus placebo.
    Specific safety endpoints assessed include:
    ? All treatment-emergent adverse events (TEAEs)
    ? Change in clinical laboratory evaluations from baseline measured at randomization to Week 13/ET for DS-5565 versus placebo
    ? Change in neurological examinations from baseline to Week 13/ET for DS-5565 versus placebo
    ? Change in electrocardiograms from baseline to Week 13/ET for DS-5565 versus placebo
    ? Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline to Week 13/ET for DS-5565 versus placebo
    El objetivo principal de seguridad es la seguridad y la tolerabilidad de las dosis ajustadas renalmente de DS-5565 frente a placebo.
    Los criterios de valoración de la seguridad específicos incluyen:
    ? Todos los acontecimientos adversos surgidos del tratamiento (AAST).
    ? Cambio en las evaluaciones analíticas clínicas desde los valores iniciales medidos en la aleatorización hasta la semana 13/RT con DS-5565 frente a placebo.
    ? Cambio en los exámenes neurológicos desde el inicio hasta la semana 13/RT con DS-5565 frente a placebo.
    ? Cambio en los electrocardiogramas desde el inicio hasta la semana 13/RT con DS-5565 frente a placebo.
    ? Cambio en la Escala de Columbia de clasificación de intensidad de las ideas suicidas (C-SSRS) desde el inicio hasta la semana 13/RT para DS-5565 frente a placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final evaluation of the primary endpoint will be done at Week 13/ET.
    La evaluación final del criterio de evaluación primario se realizará en la semana 13/RT
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints include:
    ? Changes in ADPS from baseline measured at randomization to Week 13/ET for DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes the worst pain over the previous
    24 hours.
    ? Proportion of subjects with improvement in overall status at Week 13/ET as assessed by PGIC for DS-5565 versus placebo.
    Los criterios de valoración secundarios de la eficacia incluyen:
    ? Cambios en ADPS desde los valores iniciales medidos en la aleatorización hasta la semana 13/RT con DS-5565 frente a placebo. La ADPS semanal se basa en las puntuaciones diarias del dolor indicadas por el sujeto que mejor describan el peor dolor durante las 24 horas previas.
    ? Proporción de sujetos con una mejora del estado general en la semana 13/RT evaluado por la PGIC con DS-5565 frente a placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weekly ADPS is based on daily pain scores reported by the subject (from baseline to Week 13) that best describes his or her worst pain over the previous 24 hours.
    The final evaluation of the secondary endpoints will be done at Week 13/ET.
    La ADPS semanal se basa en las puntuaciones diarias del dolor indicadas por el sujeto (desde el inicio a la semana 13) que mejor describan el peor dolor durante las 24 horas previas.
    La evaluación final de los criterios de valoración secundarios se realizará en la semana 13/RT
    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 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 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) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Poland
    Romania
    Slovakia
    South Africa
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Última Visita del Último Sujeto
    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 months6
    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 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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1
    F.4.2.2In the whole clinical trial 60
    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 Decision2015-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-06
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