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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   44399   clinical trials with a EudraCT protocol, of which   7411   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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    1,749 result(s) found. Displaying page 21 of 88.
    «« First « Previous 17  18  19  20  21  22  23  24  25  Next» Last»»
    EudraCT Number: 2016-000644-34 Sponsor Protocol Number: 108638 Start Date*: 2016-06-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, randomised, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellu...
    Medical condition: Healthy volunteers (Immunisation against diphtheria, tetanus and pertussis)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004492-23 Sponsor Protocol Number: V59P18 Start Date*: 2014-11-11
    Sponsor Name:Novartis Vaccines and Diagnostics Srl
    Full Title: A Phase 3, Single Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY vaccine administered either alone or concomitantly with a Combined ...
    Medical condition: Prophylaxis for Neisseria meningitidis serogroups A, C, W, and Y
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004820-69 Sponsor Protocol Number: CSLCT-FLU-04-05 Start Date*: 2016-08-05
    Sponsor Name:CSL Limited
    Full Title: An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).
    Medical condition: Influenza, human
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004874-13 Sponsor Protocol Number: AUG102821 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline
    Full Title: An open label study to determine the pharmacokinetic profiles of amoxicillin and clavulanate in adolescent patients weighing at least 40kg and no more than 16 years of age receiving AUGMENTIN™XR ...
    Medical condition: acute bacterial sinusitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001042-28 Sponsor Protocol Number: CONCERTAATT4080 Start Date*: 2015-04-24
    Sponsor Name:Ortho-McNeil Janssen Scientific Affairs LLC
    Full Title: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of CONCERTA on Older Children with ADHD (The ABC Study)
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10003735 Attention deficit-hyperactivity disorder LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001514-97 Sponsor Protocol Number: 114541 Start Date*: 2015-05-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 3, observer blind, randomized, non-influenza vaccine comparator-controlled, multi-country and multi-centre study of the efficacy of GSK Biologicals’ quadrivalent, inactivated, split virion,...
    Medical condition: Healthy volunteers (Immunization against influenza in male and female subjects 3 to 8 years of age inclusive)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005185-34 Sponsor Protocol Number: IPV29 Start Date*: 2015-11-19
    Sponsor Name:Sanofi Pasteur China
    Full Title: Safety study of IMOVAX Polio in selected cities in China, an observational post marketing study
    Medical condition: Poliomyelitis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001964-13 Sponsor Protocol Number: HAF85 Start Date*: 2016-05-06
    Sponsor Name:Sanofi Pasteur Korea Ltd
    Full Title: Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)
    Medical condition: Hepatitis A
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001245-89 Sponsor Protocol Number: BDR4580 Start Date*: 2015-04-13
    Sponsor Name:Sanofi-aventis
    Full Title: Relative bioavailability study between 75 mg tablet and 75 mg solution of Clopidogrel (SR25990C) after single oral administration to young healthy men. Open, crossover, randomized and monocenter study
    Medical condition: Young healthy men (intended indication cardiovascular disease)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004865 10071110 Atherothrombosis prophylaxis LLT
    Population Age: Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004636-19 Sponsor Protocol Number: ENTER_L_01486 Start Date*: 2015-04-10
    Sponsor Name:Sanofi Aventis
    Full Title: Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Da...
    Medical condition: Acute diarrhea
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10000706 Acute diarrhea LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001507-31 Sponsor Protocol Number: 111535 Start Date*: 2015-06-09
    Sponsor Name:GlaxoSmithKline Biologicals - GSK China Vaccines
    Full Title: A phase IIIb, open-label, multicentre study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa)- Haemophilus influen...
    Medical condition: Healthy volunteers (Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003246-26 Sponsor Protocol Number: HPN-100-005SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004559-29 Sponsor Protocol Number: M10-447 Start Date*: 2014-11-12
    Sponsor Name:AbbVie Inc.
    Full Title: A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-000095-38 Sponsor Protocol Number: AVXS-101-CL-303 Start Date*: 2020-03-18
    Sponsor Name:AveXis, Inc.
    Full Title: Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients with Spinal Muscular Atrophy Type 1 with One or Two SMN2 Copies Delivering AVXS-101 by Intravenous ...
    Medical condition: Gene Replacement Therapy Clinical Trial for Patients with Spinal Muscular Atrophy Type 1
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004660-37 Sponsor Protocol Number: LACAC_L_03732 Start Date*: 2015-03-25
    Sponsor Name:Sanofi
    Full Title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower
    Medical condition: Healthy volunteers (hygiene)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10042613 - Surgical and medical procedures 10053339 Routine health maintenance PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-002189-11 Sponsor Protocol Number: VX15-661-112 Start Date*: 2019-05-27
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cyst...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004335-39 Sponsor Protocol Number: N01223 Start Date*: 2015-02-16
    Sponsor Name:UCB Japan Co. Ltd.
    Full Title: An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2...
    Medical condition: Epilepsy Partial Seizures
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003260-39 Sponsor Protocol Number: ML16633 Start Date*: 2016-08-05
    Sponsor Name:F. Hoffmann-La Roche AG
    Full Title: Intravenous Granisetron (Kytril) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
    Medical condition: Prevention of Post-operative Nausea and Vomiting (PONV) in pediatric subjects
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10036901 Prophylaxis against postoperative nausea and vomiting LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000994-22 Sponsor Protocol Number: CYD71 Start Date*: 2019-06-13
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever Human Papillomavirus Disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-002064-34 Sponsor Protocol Number: B2061031 Start Date*: 2016-04-11
    Sponsor Name:Pfizer Inc.
    Full Title: A 6-MONTH, OPEN-LABEL, MULTI-CENTER, FLEXIBLE-DOSE EXTENSION STUDY TO THE B2061014 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF DESVENLAFAXINE SUCCINATE SUSTAINED-RELEASE (DVS SR) TAB...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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