Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36358   clinical trials with a EudraCT protocol, of which   5990   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-002604-41
    Sponsor's Protocol Code Number:WP6-282512
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-18
    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 number2012-002604-41
    A.3Full title of the trial
    RGNOSIS: Ecological Effects of Decolonisation Strategies in Intensive Care
    R-GNOSIS : Efectos en Cuidados Intensivos, sobre la Descontaminación ecológica, comparando diferentes estrategias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Decolonisation Strategies in Intensive Care
    estrategias de descolonización en áreas de vigilancia Intensiva
    A.3.2Name or abbreviated title of the trial where available
    RGNOSIS
    R-GNOSIS
    A.4.1Sponsor's protocol code numberWP6-282512
    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 SponsorUniversity Medical Centre Utrech
    B.1.3.4CountryNetherlands
    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 supportDirección General de Investigación de la Comisión europea
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU (servicio de Farmacología clinica).
    B.5.2Functional name of contact pointDra. Anna cruceta
    B.5.3 Address:
    B.5.3.1Street Addressvillarroel 170
    B.5.3.2Town/ citybarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+ 9322754004380
    B.5.5Fax number932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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 Yes
    D.2.1.1.1Trade name MYcostatin
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameNystatin suspension
    D.3.4Pharmaceutical form Gastroenteral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Oropharyngeal use
    Enteral use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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 Yes
    D.2.1.1.1Trade name Promixin
    D.2.1.1.2Name of the Marketing Authorisation holderProfile Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameColistin Sulphate
    D.3.4Pharmaceutical form Gastroenteral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Oropharyngeal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Tobramicina TEVA
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTobramycin
    D.3.4Pharmaceutical form Gastroenteral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Oropharyngeal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Promixin
    D.2.1.1.2Name of the Marketing Authorisation holderProfile Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameChlorhexidine digluconate
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oromucosal use
    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
    Colonisation and Infection with (multi drug resistant) Gram negative bacteria in ICU patients
    Colonización e infección con bacterias por gram negativos multirresistentes en pacientes ingresados en UCI
    E.1.1.1Medical condition in easily understood language
    Infections caused by these bacteria in ICU patients
    Infecciones causadas por estas bacterias en pacientes de la UCI
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 determine the ecological effects of decolonisation regimens (SDD, SOD and CHX-Oro) in reducing (MDR-GNB) ICU-acquired bacteremia when compared to standard care
    Para determinar los efectos ecológicos de los regímenes de Descolonización (SDD, SOD y CHX-Oro) en la reducción de bacteriemia adquirida en el ICU (MDR-GNB) en comparación con la atención estándar
    E.2.2Secondary objectives of the trial
    - To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care.
    - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB
    - To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia.
    - To quantify species-specific nosocomial transmission capacities of MDR-GNB during 3 decolonisation regimens.
    - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 and in hospital mortality
    - To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, during each phase of the study.
    Cuantificar las tasas de transmisión con MDR-GNB durante 3 regímenes de descolonización y atención estándar.
    -Para determinar la efectividad de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en la reducción de la colonización del tracto respiratorio con MDR-GNB adquirido
    -Cuantificar los efectos de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en los pacientes de ICU en el uso de antibióticos sistémico en general. -Cuantificar el nivel de ICU las asociaciones entre la colonización del tracto intestinal y respiratorio con GNB y la aparición de bacteriemia adquirida en el ICU GNB.
    -Cuantificar las capacidades de la transmisión nosocomial específicos de MDR-GNB durante 3 regímenes de descolonización.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients admitted to the Intensive Care Unit and
    - mechanically ventilated (invasive or non invasive mechanical ventilation)

    with an expected duration of mechanical ventilation > 24 hours
    Pacientes ingresados en la unidad de cuidados intensivos y
    -ventilación mecánica (invasiva o no invasiva ventilación mecánica)
    con una duración prevista de la ventilación mecánica superior a 24 horas
    E.4Principal exclusion criteria
    - preganancy
    - <18 years old
    - known allergy to any of the medications or agents used
    -embarazo
    - menores de 18 años
    -alergia conocida a alguno de los medicamentos o agentes usados
    E.5 End points
    E.5.1Primary end point(s)
    To determine the ecological effects on MDR-GNB of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patient
    Para determinar los efectos ecológicos en MDR-BNG de 3 regímenes de Descolonización (SDD, SOD y CHX-Oro) en paciente ICU
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint will be determined at discharge of the patient from the ICU
    Criterio de evaluación se determinará al alta del paciente de la UCI
    E.5.2Secondary end point(s)
    - To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care.
    - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB when compared to standard care.
    - To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use when compared to standard care.
    - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia.
    - To quantify species-specific nosocomial transmission capacities (reproductive number per hospital admission, RA) of MDR-GNB during 3 decolonisation regimens and during standard care.
    - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 mortality and in hospital mortality when compared to standard care.
    - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing ICU-acquired bacteraemia when compared to standard care (SC).
    - To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, including MRSA, VRE, MDR-GNB, Acinetobacter, S. maltophilia, and ceftazidime- and/or carbapenem resistant P. aeruginosa, during each phase of the QIP
    Cuantificar las tasas de transmisión de la Cruz con MDR-GNB durante 3 regímenes de descolonización y atención estándar.
    -Para determinar la efectividad de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en la reducción de adquirió la colonización del tracto respiratorio con MDR-GNB en comparación con la atención estándar.
    -Cuantificar los efectos de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en los pacientes de ICU sobre uso de antibióticos sistémico en general cuando se compara con la atención estándar.
    -Cuantificar el nivel de ICU las asociaciones entre la colonización del tracto intestinal y respiratorio con GNB y la aparición de bacteriemia adquirida en el ICU GNB.
    -Cuantificar las capacidades de la transmisión nosocomial específicos (número reproductivo por hospitalización, RA) de MDR-GNB durante 3 regímenes de descolonización y atención estándar.
    -Determinar la efectividad de 3 regímenes Descolonización (SDD, SOD y CHX-Oro) para reducir la mortalidad del día-28 y en la mortalidad hospitalaria en comparación con la atención estándar.
    -Determinar la efectividad de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en la reducción de bacteriemia adquirida en el ICU en comparación con la atención estándar (SC).
    -Determinar las tasas de bacteriemia ICU-adquirida causadas por cualquier microorganismo resistente a múltiples droga, incluyendo MRSA, VRE, MDR-BNG, Acinetobacter, S. maltophilia y ceftazidime-andor carbapenem resistente a p. aeruginosa, durante cada fase del QIP
    E.5.2.1Timepoint(s) of evaluation of this end point
    all secondary endpoints will be determined on discharge of the participant from the ICU, except for 28th day mortality, which will be determined on day 28 after ICU admission.
    todos los objetivos secundarios se determinarán en el alta del participante de la UCI, excepto la mortalidad día 28, que se determinará en el día 28 después de la admisión de ICU.
    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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cluster (cluster = ICU) randomised trial with cross over of interventions within each cluster
    Cluster (cluster = ICU) randomised trial with cross over of interventions within each cluster
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard care
    Standard care
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 7000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3000
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-03-18. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    ICU patients which can be sedated and or mechanically ventilated at time on enrollment. (the study will request a waiver for informed consent from the ethics committee)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10800
    F.4.2.2In the whole clinical trial 10800
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation R-GNOSIS
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA