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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 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   42891   clinical trials with a EudraCT protocol, of which   7066   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7,067 result(s) found. Displaying page 1 of 354.
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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: 2011-005612-28 Sponsor Protocol Number: 2011-11-11 Start Date*: 2012-02-27
    Sponsor Name:Hannu Kokki
    Full Title: Pharmacokinetics of oxycodone in preterm and in infants
    Medical condition: Severe pain states which need oxycodone analgesia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10042613 Surgical and medical procedures SOC
    14.1 10018065 - General disorders and administration site conditions 10033371 Pain PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (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: 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: 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: 2007-003348-31 Sponsor Protocol Number: 2007/311 Start Date*: 2008-05-15
    Sponsor Name:Department of Woman and Child health, Karolinska University Hospital
    Full Title: Progesterone at imminent premature birth Progesteron vid hotande förtidsbörd
    Medical condition: In this randomised, placebo-controlled pilot study the treatment group (n=30) will recieve a daily application of vaginal gel containing progesterone 90 mg/dose (Crinone, Seronomerck) until rupture...
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Female
    Trial protocol: SE (Ongoing)
    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: 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)
    EudraCT Number: 2006-005335-16 Sponsor Protocol Number: P051043 Start Date*: 2007-02-16
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: OMEPRAZOLE 1 - Recherche de dose et Pharmacocinétique de population de l'Oméprazole chez le nouveau-né en traitement du reflux gastro-oesophagien.
    Medical condition: Le reflux gastro-oesophagien (RGO) chez le Nouveau-Né
    Disease: Version SOC Term Classification Code Term Level
    8.1 10017924 Reflux gastro-oesophagien PT
    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: 2007-001430-14 Sponsor Protocol Number: peg-filgrastim Vs filgrastim nel t Start Date*: 2007-02-19
    Sponsor Name:AZIENDA OSPEDALIERA DI PADOVA
    Full Title: Peg-filgrastim Vs filgrastrim in pediatric patients.
    Medical condition: haematologic malignant tumors
    Disease: Version SOC Term Classification Code Term Level
    6.1 10000880 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002578-11 Sponsor Protocol Number: 917741 Start Date*: 2016-09-16
    Sponsor Name:Alder Hey Children's NHS Foundation Trust
    Full Title: The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent...
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis 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: 2005-002404-42 Sponsor Protocol Number: 17465 Start Date*: 2005-08-18
    Sponsor Name:University of Dundee
    Full Title: A pilot study to inform a randomised controlled trial of iodine supplementation in preterm infants
    Medical condition: transient hypothyroxinaemia
    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: 2005-003007-36 Sponsor Protocol Number: HP002A Start Date*: 2006-08-02
    Sponsor Name:Imperial College London [...]
    1. Imperial College London
    2. BOC Ltd.
    Full Title: B.R.E.A.T.H.E. Bronchiolitis RCT: Emergency Assisted Therapy with Heliox - an Evaluation. A Prospective, Double-Blinded, Randomised, Controlled Clinical Trial to assess the effect of helium-oxygen ...
    Medical condition: Bronchiolitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10006448 Bronchiolitis 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: 2009-012817-23 Sponsor Protocol Number: MRU-09-02 Start Date*: 2009-09-08
    Sponsor Name:Maternite Regionale Universitaire de Nancy
    Full Title: Utilisation d’un surfactant exogène chez des nouveau-nés grands prématurés présentant une détresse respiratoire sévère en prévention de la dysplasie bronchopulmonaire
    Medical condition: Nouveau-né d’âge gestationnel inférieur à 33 semaines d’aménorrhée toujours sous ventilation assistée conventionnelle ou par oscillations à hautes fréquences (OHF), après 14+/-2 jours de vie, avec ...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
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    The status of studies in GB is no longer updated from 1.1.2021
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