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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   44381   clinical trials with a EudraCT protocol, of which   7393   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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    4,463 result(s) found. Displaying page 184 of 224.
    «« First « Previous 180  181  182  183  184  185  186  187  188  Next» Last»»
    EudraCT Number: 2014-002666-76 Sponsor Protocol Number: 200363 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An open-label study to characterize the pharmacokinetics and pharmacodynamics of mepolizumab administered subcutaneously in children from 6 to 11 years of age with severe eosinophilic asthma
    Medical condition: Severe Eosinophilic Asthma
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004855 10068462 Eosinophilic asthma LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-005496-14 Sponsor Protocol Number: MRZ60201_3072_1 Start Date*: Information not available in EudraCT
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, multicenter, randomized, double-blind, parallel-group, dose-response study of three doses Xeomin® (incobotulinumtoxinA, NT 201) for the treatment of upper limb spasticity alone or comb...
    Medical condition: Upper limb spasticity or combined upper and lower limb spasticity in children and adolescents (age 2 - 17 years) with cerebral palsy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10058977 Spastic paresis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002941-23 Sponsor Protocol Number: GWEP1423 Start Date*: 2015-09-30
    Sponsor Name:GW Research Ltd.
    Full Title: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syn...
    Medical condition: Lennox-Gastaut syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10048816 Lennox-Gastaut syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003400-39 Sponsor Protocol Number: NGLU-CL02 Start Date*: 2014-07-15
    Sponsor Name:Alexion Pharmaceuticals, Inc.
    Full Title: A Phase I/II Open Label Study in MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
    Medical condition: Mucopolysaccharidosis III, type B (MPS IIIB), Sanfilippo B
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    19.0 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Temporarily Halted)
    Trial results: View results
    EudraCT Number: 2011-006013-34 Sponsor Protocol Number: 115884 Start Date*: 2013-01-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled, multi-centric study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine when administered to childr...
    Medical condition: Active immunization against disease caused by Streptococcus pneumoniae in children 2-17 years of age who are at increased risk of pneumococcal infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    14.1 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    14.1 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    15.1 100000004862 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-000658-67 Sponsor Protocol Number: DEEP-1 Start Date*: 2012-07-31
    Sponsor Name:Consorzio per Valutazioni Biologiche e Farmacologiche
    Full Title: Multi-centre, oral single dose experimental and modelling study to evaluate the pharmacokinetics of deferiprone in patients aged from 1 month to less than 6 years of age affected by transfusion-dep...
    Medical condition: chronic iron overload
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004861 10065974 Chronic iron overload LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002582-35 Sponsor Protocol Number: MCI-196-E16 Start Date*: 2013-03-14
    Sponsor Name:Mitsubishi Tanabe Pharma Corporation (MTPC)
    Full Title: A Multi-centre, Open-label Study Evaluating the Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects with Chronic Kidney Disease Stages 3b to 5 and with Hyperphosphataemia not on ...
    Medical condition: Hyperphosphataemia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10027433 - Metabolism and nutrition disorders 10020711 Hyperphosphataemia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000389-39 Sponsor Protocol Number: VX12-770-112 Start Date*: 2012-10-25
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-006749-18 Sponsor Protocol Number: HE06-001-C P4 Start Date*: 2009-06-26
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: Efficacy and safety of 6 % hydroxyethyl starch 130/0.4 (Voluven®) vs. 5% HSA in volume replacement therapy during elective open-heart surgery in paediatric patients
    Medical condition: Volume replacement therapy during elective open-heart surgery in paediatric patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10048935 Open heart surgery LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002246-41 Sponsor Protocol Number: BP29420 Start Date*: 2014-10-23
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO6885247 FOLLOWING 12 WEEKS OF T...
    Medical condition: Spinal Muscular Atrophy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-002427-28 Sponsor Protocol Number: CIT-003-01 Start Date*: 2018-10-24
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: A Phase III Double-Blind, Randomized, Placebo Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Intravenous L-citrulline for the Prevention of Clinical Sequelae of Acut...
    Medical condition: Post-operative pulmonary dysfunction induced by cardiopulmonary bypass in pediatric subjects undergoing surgery for congenital heart defects.
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004613-34 Sponsor Protocol Number: NordLOTS protocol 1.4 Start Date*: 2008-03-14
    Sponsor Name:The Centre for Child and Adolescent Mental Health, Eastern and Southern Norway (R.BUP)
    Full Title: Nordic Longterm OCD treatment Study: A Nordic Multicenter treatment study evaluating a stepped care model based on the "Expert Clinical Guidelines". The study is performed with no sponsor from phar...
    Medical condition: Obsessive Compulsive Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049596 Obsession LLT
    9.1 10010219 Compulsions LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005855-61 Sponsor Protocol Number: 1100.1518 Start Date*: 2009-05-20
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An open-label, multiple dose, cross-over study to evaluate the steady-state pharmacokinetic parameters of nevirapine extended release tablets in HIV-1 infected children, with an optional extension ...
    Medical condition: HIV-1 infected children under antiretroviral therapy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022872-30 Sponsor Protocol Number: PALO-10-20 Start Date*: 2011-08-04
    Sponsor Name:Helsinn Healthcare SA
    Full Title: A multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of two different doses of palonosetron compared to ondansetron in the prevention of CINV in pediatr...
    Medical condition: Study to evaluate the efficacy and safety of two different doses of palonosetron compared to ondansetron in the prevention of CINV in pediatric patients undergoing single and repeated cycles of MEC...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10042613 - Surgical and medical procedures 10049091 Chemotherapy antiemetic prophylaxis LLT
    13.1 10042613 - Surgical and medical procedures 10036899 Prophylaxis against chemotherapy induced vomiting LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) AT (Completed) BG (Completed) EE (Completed) DE (Completed) FR (Ongoing) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-003401-26 Sponsor Protocol Number: 400-12-006 Start Date*: 2014-05-16
    Sponsor Name:Ethicon Inc.
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery in Pediatric P...
    Medical condition: Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018730-51 Sponsor Protocol Number: 113977 Start Date*: 2010-11-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open, multi-centre, controlled study to assess the long-term persistence of antibodies after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus-t...
    Medical condition: Vaccination of children 2 to 10 years of age against invasive disease caused by meningococcal serogroups A, C, W-135, and Y.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10027274 Meningococcal infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-015817-31 Sponsor Protocol Number: OC3-DB-02 Start Date*: 2009-12-01
    Sponsor Name:OxThera IP AB
    Full Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria
    Medical condition: primary hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    12.0 10020703 Hyperoxaluria LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-010108-27 Sponsor Protocol Number: P05574 Start Date*: 2012-10-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and B...
    Medical condition: Children 5 to 11 years of age with persistent asthma.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006220-19 Sponsor Protocol Number: SUM-2006/01-INT Start Date*: 2008-11-27
    Sponsor Name:PLIVA Hrvatska d.o.o.
    Full Title: Safety and Efficacy of Sumamed® Therapy in the Treatment of Respiratory Tract Infections in Adults and Children: International, Multicenter, Non-Comparative Study
    Medical condition: acute pharyngitis/tonsilitis acute sinusitis acute otitis media acute exacerbation of chronic bronchitis community acquired pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001002 Acute pharyngitis LLT
    9.1 10001093 Acute tonsillitis LLT
    9.1 10001076 Acute sinusitis LLT
    9.1 10033079 Otitis media acute LLT
    9.1 10000743 Acute exacerbation of chronic bronchitis LLT
    9.1 10010120 Community acquired pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed) CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-003359-19 Sponsor Protocol Number: GALPED1001 Start Date*: 2007-08-07
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome
    Medical condition: Children with Down syndrom
    Disease: Version SOC Term Classification Code Term Level
    8.1 10013616 Down's syndrome LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    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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