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Clinical trials for Medical Device Reporting

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    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.
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    75 result(s) found for: Medical Device Reporting. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2012-000867-25 Sponsor Protocol Number: OMS302-ILR-004 Start Date*: 2012-07-23
    Sponsor Name:Omeros Corporation
    Full Title: A Phase 3 Randomised, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Un...
    Medical condition: Intraocular Lens Replacement with Pharmacoemulsification
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004865 10054771 Intraocular lens replacement LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003997-33 Sponsor Protocol Number: NOAH-AFNET6 Start Date*: 2016-11-18
    Sponsor Name:Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]
    Full Title: Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes
    Medical condition: Atrial fibrillation (AF) is one cause of stroke. Stroke rate is increased in patients with atrial high rate episodes (AHRE, an early stage of AF) as well, even if stroke rates are lower when compa...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004849 10003656 Atrial arrhythmia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) AT (Prematurely Ended) NL (Prematurely Ended) BG (Completed) SE (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) PT (Prematurely Ended) GR (Completed) DK (Prematurely Ended) IT (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004971-30 Sponsor Protocol Number: FLUGEN-H3N2-V002 Start Date*: 2018-04-27
    Sponsor Name:FluGen, Inc
    Full Title: A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranas...
    Medical condition: Prophylactic H3N2(A/Brisbane/10/2007) monovalent influenza vaccine, Bris10 M2SR, for protection against influenza disease caused by seasonal influenza A viruses.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022005 Influenza viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023873-20 Sponsor Protocol Number: B1971009(6108A1-3001) Start Date*: 2011-11-08
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MENINGOCOCCAL SEROGROUP B BIVALENT RLP2086 VACCINE IN H...
    Medical condition: BACTERIAL MENINGITIS.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10004049 Bacterial meningitis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) FI (Completed) CZ (Completed) GB (Completed) ES (Completed) PL (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-000173-29 Sponsor Protocol Number: N01237 Start Date*: 2006-04-13
    Sponsor Name:UCB S.A. (Global Medical Affairs)
    Full Title: A multicenter, open-label single-arm follow-up trial evaluating the long-term safety of levetiracetam, for patients suffering from epilepsy and coming from the study N01175.
    Medical condition: Epilepsy
    Disease: Version SOC Term Classification Code Term Level
    8.1 10061334 LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003693-31 Sponsor Protocol Number: C3671013 Start Date*: 2021-09-30
    Sponsor Name:Pfizer Inc., 66 Hudson Boulevard East New York, NY 10001
    Full Title: A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
    Medical condition: Prevention of RSV-associated lower respiratory tract illness in adults 60 years of age and older by active immunization
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001259-29 Sponsor Protocol Number: UoL001306 Start Date*: 2019-03-12
    Sponsor Name:University of LIverpool
    Full Title: A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ΔF508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-...
    Medical condition: DeltaF508 Homozygous Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002780-42 Sponsor Protocol Number: TR701-111 Start Date*: 2015-06-29
    Sponsor Name:Trius Therapeutics [...]
    1. Trius Therapeutics
    2. Cubist Pharmaceuticals, Inc
    Full Title: A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Ad...
    Medical condition: Acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    18.0 10022891 - Investigations 10040879 Skin investigations HLGT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000013-20 Sponsor Protocol Number: 2018-000013-20 Start Date*: 2018-05-07
    Sponsor Name:KU Leuven
    Full Title: Placebo-controlled crossover study of the ability of Naloxegol to reverse opioid effect on colonic motor patterns in healthy volunteers
    Medical condition: This study will be performed in healthy volunteers.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000091-14 Sponsor Protocol Number: FFR102123 Start Date*: 2004-09-17
    Sponsor Name:GlaxoSmithKline, S.A
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Long-Term Study to Evaluate the Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg ...
    Medical condition: Perennial allergic rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) LV (Completed) LT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003475-13 Sponsor Protocol Number: A1281148 Start Date*: 2006-12-08
    Sponsor Name:Pfizer Pharma GmbH
    Full Title: A SIXTEEN-WEEK, MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND EFFICACY OF SWITCHING FROM QUETIAPINE TO ZIPRASIDONE IN SUBJECTS DIAGNOSED WITH SCHIZOPHRENIA OR SCHIZOAFFECT...
    Medical condition: Schizophrenia and Schizoaffective Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039635 Schizophrenia schizoaffective LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004564-38 Sponsor Protocol Number: KFL3501 Start Date*: 2015-05-27
    Sponsor Name:Mundipharma Research Limited
    Full Title: A randomised, open label, two-period, cross-over, multi-centre study to compare correct inhaler handling of fluticasone/ formoterol breath-actuated inhaler (K-haler®) with that of Symbicort® Turboh...
    Medical condition: Asthma, Asthma-COPD Overlap Syndrome (ACOS) and Chronic Obstructive Pulmonary Disease.
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003555 Asthma bronchial LLT
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009028 Chronic obstructive asthma (with obstructive pulmonary disease) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-001673-75 Sponsor Protocol Number: ABX464-401 Start Date*: 2020-05-06
    Sponsor Name:ABIVAX
    Full Title: A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failu...
    Medical condition: COVID-19 infection (infection with SARS-CoV-2 virus)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) BE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001795-34 Sponsor Protocol Number: CL-N-HTX-Paed-II/10/20 Start Date*: 2023-01-30
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children
    Medical condition: Preservation of hearts prior to heart transplantation in children
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10019314 Heart transplant PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000369-37 Sponsor Protocol Number: NKT102245 Start Date*: 2005-02-01
    Sponsor Name:GlaxoSmithKline Group of Companies
    Full Title: A multicentre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of oral dosing with GW679769 (50 mg or 150 mg) for 3 consecutive days in conjun...
    Medical condition: Post Operative Nausea and Vomiting (PONV) Post Discharge Nausea and Vomiting (PDNV)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) GB (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2009-017838-44 Sponsor Protocol Number: CJO-201 Start Date*: 2010-04-21
    Sponsor Name:Sequel Pharmaceuticals, Inc.
    Full Title: A Pilot Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Centered Safety, Tolerability and Preliminary Efficacy Study of K201 Oral for the Prevention of Atrial Fibrillation (AF) Recurre...
    Medical condition: Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FI (Prematurely Ended) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-005926-22 Sponsor Protocol Number: FLT3501 Start Date*: 2007-03-14
    Sponsor Name:Mundipharma Research Ltd.
    Full Title: An open, randomised, parallel group, multicentre study to compare the efficacy and safety of FlutiForm pMDI vs Seretide pMDI in adult subjects with mild to moderate-severe persistent, reversible as...
    Medical condition: Asthma bronchial
    Disease: Version SOC Term Classification Code Term Level
    8.1 10003555 Asthma bronchial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2008-000499-25 Sponsor Protocol Number: 28733 Start Date*: Information not available in EudraCT
    Sponsor Name:Merck Serono International S.A.
    Full Title: International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patien...
    Medical condition: Relapsing forms of Multiple Sclerosis (RMS)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003663-35 Sponsor Protocol Number: PBF-680CT-05 Start Date*: 2018-06-13
    Sponsor Name:Palobiofarma S.L
    Full Title: A phase II, double-blind, randomized, parallel-group, placebocontrolled multi-center study to investigate the effect of the adenosine A1 receptor antagonist PBF-680 on forced expiratory volume in 1...
    Medical condition: patients with mild-to-moderate persistent atopic asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10003638 Atopic asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001561-32 Sponsor Protocol Number: 201900237 Start Date*: 2020-04-28
    Sponsor Name:University Medical Center Groningen
    Full Title: Dupilumab in adults with severe chronic hand eczema with an inadequate response or intolerance to alitretinoin: a randomized, double-blind, placebo-controlled proof of concept efficacy study
    Medical condition: Hand eczema
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10066695 Chronic hand dermatitis LLT
    20.0 100000004858 10036145 Pompholyx eczema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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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