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Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7,377 result(s) found. Displaying page 1 of 369.
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    EudraCT Number: 2009-016877-14 Sponsor Protocol Number: H1N1-2009 Start Date*: 2009-11-04
    Sponsor Name:COPSAC
    Full Title: H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A-H1N1v Vaccination in Pregnant Women
    Medical condition: Protection against Influenza A H1N1v disease
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-010722-19 Sponsor Protocol Number: BI71023_3001 Start Date*: 2009-11-04
    Sponsor Name:CSL Behring LLC
    Full Title: A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII Deficiency Estudio prospectivo, multicéntrico, con et...
    Medical condition: Congenital Factor XIII deficiency Deficiencia congénita de factor XIII
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016083 Factor XIII deficiency LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-022370-14 Sponsor Protocol Number: 1015202 Start Date*: Information not available in EudraCT
    Sponsor Name:Centre Hospitalier de Toulouse
    Full Title: Evaluation de la tolérance d'une administration intra-nasale d'ocytocine chez des nourrissons présentant un syndrome de Prader-Willi et de son effet sur la succion et la prise alimentaire.
    Medical condition: Syndrome de Prader Willi
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036476 Prader-Willi syndrome LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002342-21 Sponsor Protocol Number: KB055 Start Date*: 2014-07-29
    Sponsor Name:Kedrion S.P.A
    Full Title:
    Medical condition:
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-001189-40 Sponsor Protocol Number: 3 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Tartu
    Full Title: PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE
    Medical condition: cardiac failure, ascites and/or oedema
    Disease: Version SOC Term Classification Code Term Level
    17.0 10007541 - Cardiac disorders 10010394 Congenital cardiac disorders HLGT
    17.0 10018065 - General disorders and administration site conditions 10049630 Oedema due to renal disease PT
    17.0 10018065 - General disorders and administration site conditions 10030103 Oedema generalized LLT
    17.0 10017947 - Gastrointestinal disorders 10003445 Ascites PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001024-31 Sponsor Protocol Number: 08/S0501/31 Start Date*: 2008-08-27
    Sponsor Name:University of Oxford
    Full Title: A randomised controlled trial of iodide supplementation in preterm infants with follow-up at 2 years
    Medical condition: Transient hyothyroxinaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004860 10043710 Thyroid disorder NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-005738-12 Sponsor Protocol Number: LIPSTIC.V.01 Start Date*: 2013-03-27
    Sponsor Name:Alder Hey Children's NHS Foundation Trust
    Full Title: Liverpool Pharmacokinetic/pharmacodynamics study of teicoplanin in children (LIPSTIC).
    Medical condition: Gram-positive bacterial infection: late-onset neonatal sepsis, central line-associated blood stream infection, ventilator-associated pneumonia.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002823-27 Sponsor Protocol Number: GAVALAGG Start Date*: 2016-11-17
    Sponsor Name:INFECTOPHARM Arzneimittel GmbH
    Full Title: Placebo-kontrollierte, multizentrische, randomisierte, doppelblinde Phase III-Studie zur Verbesserung der gastrointestinalen Verträglichkeit einer per-oralen Antibiotikatherapie durch add-on-Gabe v...
    Medical condition: Verbesserung der gastrointestinalen Verträglichkeit einer per-oralen Antibiotikatherapie
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10055956 Antibiotic-associated diarrhoea LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-001169-18 Sponsor Protocol Number: UoL001360 Start Date*: 2018-10-15
    Sponsor Name:University Of Liverpool
    Full Title: The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: The Bronchiolitis Endotracheal Surfactant Study.
    Medical condition: Critical Illness due to Bronchiolitis of infancy requiring conventional invasive Mechanical Ventilation (MV) Diagnosis of bronchiolitis per clinical criteria defined in national guidance NICE-NG9.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    20.1 10021881 - Infections and infestations 10065188 Lower respiratory tract infection viral PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-001113-21 Sponsor Protocol Number: NDPHRECOVERY Start Date*: 2020-03-17
    Sponsor Name:University of Oxford
    Full Title: Randomised Evaluation of COVID-19 Therapy (RECOVERY)
    Medical condition: COVID-19 (infection with SARS-CoV-2 virus)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    20.1 10021881 - Infections and infestations 10061982 Severe acute respiratory syndrome PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-016731-34 Sponsor Protocol Number: CRO1413 Start Date*: 2010-01-08
    Sponsor Name:Imperial College
    Full Title: Amino acid regimen and intravenous lipid composition in preterm parenteral nutrition: a randomised double blind controlled trial of Nutritional Evaluation and Optimisation in Neonates.
    Medical condition: Preterm birth
    Disease: Version SOC Term Classification Code Term Level
    12.0 10036594 Premature birth LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002345-39 Sponsor Protocol Number: Göteborg University Start Date*: 2006-02-16
    Sponsor Name:NOPHO NHL-group
    Full Title: B-NHL BFM 04
    Medical condition: B-cell lymphoma or B-ALL in children up to 18 years of age
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002198-44 Sponsor Protocol Number: P903-21 Start Date*: 2011-07-22
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
    Medical condition: Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021295-28 Sponsor Protocol Number: ottavi Start Date*: 2010-09-30
    Sponsor Name:AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA` DI NOVARA
    Full Title: therapy antiedemigena through administration of corticosteroidi after surgical extraction of the teeth of the judgment.
    Medical condition: This study is going to be performed on patients afferent to the service of Chirurgia Maxillo Facciale dell’Ospedale Maggiore della Carita` di Novara subject to eights bony included extraction.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042613 SOC
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005497-28 Sponsor Protocol Number: PedMic Start Date*: 2013-09-27
    Sponsor Name:Erasmus MC - Sophia
    Full Title: Pediatric Microdosing: elucidating age-related changes in oral absorption
    Medical condition: Age-related changes in intestinal drug metabolism in children
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-014892-31 Sponsor Protocol Number: MAIVECMOPAIN Start Date*: 2009-11-10
    Sponsor Name:ErasmusMC - Sophia
    Full Title: Morphine intravenous vs. Paracetamol intravenous in children on ECMO
    Medical condition: Patients treated with Extra Corporal Membrane Oxygenation (ECMO) receive morphine as standardised analgesic drug. Morphine is associated with several side effects. In these patients a non-opioid dr...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-001996-13 Sponsor Protocol Number: Tirofiban-Urokinasi 2007 Start Date*: 2007-06-06
    Sponsor Name:AZIENDA OSPEDALIERA SENESE
    Full Title: Intravenous glycoprotein IIbIIIa inhibitor (Tirofiban) combined with low dose of intra-arterial Urokinase for the endovascolar treatment of patients with acute major ischemic stroke
    Medical condition: patients with major ischemic stroke not suitable for other authorized treatment for riperfusion of the ischemic area
    Disease: Version SOC Term Classification Code Term Level
    6.1 10057613 PT
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-001569-16 Sponsor Protocol Number: VITPED/P01/04/MU.UK Start Date*: 2006-07-17
    Sponsor Name:BAXTER SAS R&D Parenteral Nutrition
    Full Title: EFFICIENCY AND SAFETY OF CLINAVIT PAEDIATRIC AT A WEIGHT DEPENDANT DOSE ADMINISTERED DAILY FOR 5 CONTINUOUS DAYS ON 4 VITAMINS BLOOD LEVEL IN NEONATES AND CHILDREN UP TO 11 YEARS OF AGE RECEIVING P...
    Medical condition: No special medical condition but Patient requiring for any underlying pathology at least 5 days of total parenteral nutrition, representing at least 90% of their total energy needs
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-003781-42 Sponsor Protocol Number: 17465 Start Date*: 2005-09-21
    Sponsor Name:University of Dundee
    Full Title:
    Medical condition: Transient hypothyroxinanaemia
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-024387-17 Sponsor Protocol Number: CPI-CL-012 Start Date*: 2012-05-16
    Sponsor Name:Cumberland Pharmaceuticals Inc.
    Full Title: A Multi-center, Randomized, Open-Label, Parallel, Active-Comparator, Multiple Dose Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Pediatric Patients
    Medical condition: fever
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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