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Clinical trials for Confirmatory trial

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    299 result(s) found for: Confirmatory trial. Displaying page 1 of 15.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2014-003066-24 Sponsor Protocol Number: MW2012-01-01 Start Date*: 2014-12-17
    Sponsor Name:MediWound Ltd.
    Full Title: A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SO...
    Medical condition: The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compa...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004863 10043418 Thermal burns HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) SK (Completed) DE (Completed) BE (Completed) AT (Prematurely Ended) BG (Prematurely Ended) NL (Prematurely Ended) FR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001041-20 Sponsor Protocol Number: F001AM0222_1 Start Date*: 2022-10-14
    Sponsor Name:University Hospital Wuerzburg
    Full Title: Prednisolone and vitamin B1, B6, and B12 in patients with Post-COVID-19-Syndrome (PC19S) – a randomized controlled trial in primary care
    Medical condition: Post-COVID-19-Syndrome (PC19S)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004949-32 Sponsor Protocol Number: P1-GM-101 Start Date*: 2021-03-30
    Sponsor Name:Lysogene
    Full Title: An open-label adaptive-design study of intracisternal administration of adeno-associated viral vector serotype rh.10 carrying the human β-galactosidase cDNA for the treatment of GM1 gangliosidosis
    Medical condition: GM1 gangliosidosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000174-29 Sponsor Protocol Number: CNS7056-022 Start Date*: 2018-07-25
    Sponsor Name:PAION UK Limited
    Full Title: Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery
    Medical condition: Induction and maintenance of general anaesthesia (GA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10018061 General anesthesia LLT
    20.0 100000004865 10054434 Induction and maintenance of anesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) GB (Prematurely Ended) NL (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005654-21 Sponsor Protocol Number: 13957 Start Date*: 2009-09-11
    Sponsor Name:Bayer Consumer Care AG
    Full Title: An investigator-blind, randomized, multicenter, 5-arm, placebo- and active controlled parallel group pilot trial to explore the efficacy and tolerability of topical bifonazole liquid spray in patie...
    Medical condition: Athlete’s foot, moderate severity.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10003621 Athlete's foot LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-001996-39 Sponsor Protocol Number: A2171069 Start Date*: 2006-07-13
    Sponsor Name:Pfizer Pharma GmbH
    Full Title: AN INTERNATIONAL, MULTICENTER, LARGE SIMPLE TRIAL (LST) TO EVALUATE THE LONG-TERM PULMONARY AND CARDIOVASCULAR SAFETY OF EXUBERA® IN PATIENTS WITH DIABETES MELLITUS
    Medical condition: Diabetes Mellitus Type I and Type II
    Disease: Version SOC Term Classification Code Term Level
    8.1 10012601 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-000323-17 Sponsor Protocol Number: XRP6976J/3503 Start Date*: 2007-05-29
    Sponsor Name:sanofi-aventis US
    Full Title: A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following...
    Medical condition: Clinically asymptomatic prostate cancer subject with a rising PSA following definitive local therapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060862 Prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Prematurely Ended) LT (Prematurely Ended) CZ (Prematurely Ended) SK (Completed) DE (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005828-11 Sponsor Protocol Number: SAVE-MORE Start Date*: 2020-12-16
    Sponsor Name:Hellenic Institute for the Study of Sepsis
    Full Title: suPAR-GUIDED ANAKINRA TREATMENT FOR VALIDATION OF THE RISK AND EARLY MANAGEMENT OF SEVERE RESPIRATORY FAILURE BY COVID-19: THE SAVE-MORE DOUBLE-BLIND, RANDOMIZED, PHASE III CONFIRMATORY TRIAL
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10035738 Pneumonia viral NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-003176-38 Sponsor Protocol Number: 135.312 Start Date*: 2006-05-22
    Sponsor Name:Boehringer Ingelheim Pharma Ges mbH
    Full Title: A placebo controlled trial of alteplase (rt-PA) in acute ischemic hemispheric stroke where thrombolysis is initiated between 3 and 4 hours 30 minutes after stroke onset
    Medical condition: Ischemic stroke 3 and 4 hours 30 minutes before treatment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-003368-29 Sponsor Protocol Number: VAS203/III/1/04 Start Date*: 2016-05-31
    Sponsor Name:vasopharm GmbH
    Full Title: EFFICACY OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY. A confirmatory, placebo-controlled, randomised, double blind, multi-centre study.
    Medical condition: Moderate and severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10060690 Traumatic brain injury LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-004280-31 Sponsor Protocol Number: 04/280507 Start Date*: 2006-02-02
    Sponsor Name:University of Dundee
    Full Title: Hyperthermic Intraperitoneal Chemotherapy - Gastric Cancer
    Medical condition: Gastric Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003050-96 Sponsor Protocol Number: 04EU/BMT06 Start Date*: 2005-12-02
    Sponsor Name:IBSA
    Full Title: Multicentre, prospective, assessor-blind, in parallel groups randomised and vs reference marketed product controlled confirmatory trial of the efficacy and safety of IBSA BMV medicated plaster for ...
    Medical condition: chronic plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033898 Parapsoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003287-37 Sponsor Protocol Number: EMR200588-002 Start Date*: 2016-03-15
    Sponsor Name:Merck KGaA
    Full Title: A randomized, double-blind, confirmatory trial to evaluate the efficacy, safety and immunogenicity of MSB11022 compared with European Union-Approved Humira® in subjects with moderate to severe chro...
    Medical condition: moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) DE (Completed) GB (Completed) CZ (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2020-002190-10 Sponsor Protocol Number: UCDCRC/20/03 Start Date*: 2021-02-05
    Sponsor Name:University College Dublin
    Full Title: Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG)
    Medical condition: Coagulopathy of COVID-19 appears to afflict approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by ele...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003381-40 Sponsor Protocol Number: BED-PSMA-301 Start Date*: 2020-06-22
    Sponsor Name:Blue Earth Diagnostics Ireland Ltd.
    Full Title: A prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA-7.3 (18F) PET ligand in men with newly diagnosed prostate cancer
    Medical condition: Prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) FI (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-004333-57 Sponsor Protocol Number: N01221 Start Date*: 2015-02-10
    Sponsor Name:UCB Japan Co., Ltd.
    Full Title: A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam used as add-on Therapy at doses of 0.5 to 3 g/day in Patients From 1...
    Medical condition: Epilepsies Partial
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-001910-13 Sponsor Protocol Number: AV-101-002 Start Date*: 2022-02-21
    Sponsor Name:Aerovate Therapeutics, Inc.
    Full Title: IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hy...
    Medical condition: Pulmonary Arterial Hypertension (PAH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077729 Pulmonary arterial hypertension WHO functional class III LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077730 Pulmonary arterial hypertension WHO functional class IV LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077740 Pulmonary arterial hypertension WHO functional class II LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) CZ (Trial now transitioned) GR (Trial now transitioned) PT (Trial now transitioned) IE (Trial now transitioned) AT (Trial now transitioned) LV (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000342-19 Sponsor Protocol Number: IIT-2017/02 Start Date*: 2018-10-18
    Sponsor Name:Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
    Full Title: Prospective, randomized, double-blind clinical trial phase II for the anti-inflammatory effects of Curazink (zinc histidine) for 8 weeks in elderly patients with mild cognitive impairment in Alzhei...
    Medical condition: Included are patients with the presence of a moderate or pronounced zinc deficienc and the diagnosis of a mild cognitive disorder, which may be due to an additional investigation (amyloid PET and /...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-005686-11 Sponsor Protocol Number: SP878 Start Date*: 2006-02-21
    Sponsor Name:SCHWARZ PHARMA Deutschland GmbH
    Full Title: CONFIRMATORY, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUPS STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROSTAGLANDIN E1 IN SUBJECTS WITH DRY AGE-RELATED MACULAR DEGENER...
    Medical condition: Patients with dry age-related macular degeneration
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003259-39 Sponsor Protocol Number: NeuroClin02 Start Date*: 2014-03-28
    Sponsor Name:Neurochlore
    Full Title: A Phase II dose ranging study of Bumetanide solution in children and adolescents with autism spectrum disorders.
    Medical condition: Diseases and Related Health Problems, tenth revision (ICD-10) and with a Childhood Autism Rating Scale (CARS) score > 34.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed)
    Trial results: View results
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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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