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Clinical trials for Febuxostat

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   44336   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 ).  
     
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    17 result(s) found for: Febuxostat. Displaying page 1 of 1.
    EudraCT Number: 2011-003768-55 Sponsor Protocol Number: RDEA594-304 Start Date*: 2012-05-14
    Sponsor Name:Ardea Biosciences, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering S...
    Medical condition: Tophaceous Gout
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-001858-25 Sponsor Protocol Number: MEIN/11/FEB-GOU/001 Start Date*: 2013-01-28
    Sponsor Name:MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
    Full Title: A multicentre, randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum...
    Medical condition: hyperuricemia and gout
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    14.1 10027433 - Metabolism and nutrition disorders 10020907 Hyperuricemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) IT (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-001445-61 Sponsor Protocol Number: FLO-02 Start Date*: 2016-09-12
    Sponsor Name:Menarini Ricerche S.p.A.
    Full Title: Open label, multi-centre, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD) and safety of febuxostat between pediatric patients (≥6<18 years of age) and adults.
    Medical condition: Hematological malignancies at intermediate to high risk of Tumor Lysis Syndrome ( TLS) prevention.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10045170 Tumour lysis syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002185-40 Sponsor Protocol Number: LSH-21-001 Start Date*: 2022-10-06
    Sponsor Name:Landspitali - The National University Hospital of Iceland
    Full Title: Comparison of the Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion and Plasma Levels in Patients with Adenine Phosphoribosyltransferase Deficiency: A Clinical Trial
    Medical condition: Adenine phosphoribosyltransferase deficiency
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IS (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004766-19 Sponsor Protocol Number: 2017/386/HP Start Date*: 2021-08-02
    Sponsor Name:University Hospital Centre of Rouen
    Full Title: Non-inferiority study of a new therapeutic strategy for gout: immediate prescription of a hypouricemia treatment, febuxostat, compared to its deferred administration.
    Medical condition: Patients with gout attacks
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-001883-23 Sponsor Protocol Number: 2011CV08 Start Date*: 2011-08-03
    Sponsor Name:University of Dundee
    Full Title: FAST- Febuxostat versus Allopurinol Streamlined Trial A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in co...
    Medical condition: Chronic symptomatic hyperuricaemic
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) FI (Prematurely Ended) SE (Completed)
    Trial results: View results
    EudraCT Number: 2008-007784-16 Sponsor Protocol Number: IL1T-GA-0815 Start Date*: 2010-01-05
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy.
    Medical condition: Gout flares
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064900 Gout flare LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005567-33 Sponsor Protocol Number: MEIN/14/FEB-PWV/001 Start Date*: 2015-09-11
    Sponsor Name:Menarini International Operations Luxembourg S.A.
    Full Title: The Effect of Intensive Urate Lowering Therapy (ULT) with Febuxostat in Comparison with Allopurinol on Cardiovascular Risk in Patients with Gout Using Surrogate Markers: a Randomized, Controlled Tr...
    Medical condition: Gout
    Disease: Version SOC Term Classification Code Term Level
    17.1 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) PL (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000776-42 Sponsor Protocol Number: FLO-01 Start Date*: 2012-09-17
    Sponsor Name:Menarini Ricerche S.p.A.
    Full Title: Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study versus Allopurinol
    Medical condition: Tumor Lysis Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10045170 Tumour lysis syndrome PT
    14.1 10027433 - Metabolism and nutrition disorders 10045152 Tumor lysis syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) CZ (Completed) HU (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-005730-15 Sponsor Protocol Number: GO-TEST-FINALE Start Date*: 2021-01-26
    Sponsor Name:Sint Maartenskliniek
    Full Title: GOut TrEatment STrategy (GO TEST) FINALE study, a multicentre pragmatic randomized superiority trial of continuation versus cessation of urate lowering therapies in gout in remission.
    Medical condition: Gout, arthritis urica
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005721-82 Sponsor Protocol Number: NL74873.091.20 Start Date*: 2021-02-08
    Sponsor Name:VieCuri
    Full Title: The Gout TrEatment STrategy Project (GO TEST) Overture trial
    Medical condition: gout
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003756-39 Sponsor Protocol Number: RDEA594-303 Start Date*: 2012-04-10
    Sponsor Name:Ardea Biosciences, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects with Gout and an Intolerance or...
    Medical condition: Gout
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000975-33 Sponsor Protocol Number: RDCRN_RKSC_6412 Start Date*: 2013-11-19
    Sponsor Name:Landspitali - The National University Hospital of Iceland
    Full Title: Novel Assays for the Determination of Urinary 2,8-Dihydroxyadenine and Other Key Urinary Purine Metabolites - Rare Diseases Clinical Research Network Protocol Version 1
    Medical condition: Adenine phosphoribosyltransferase deficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IS (Completed)
    Trial results: View results
    EudraCT Number: 2009-015018-23 Sponsor Protocol Number: CACZ885H2356 Start Date*: 2009-12-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/or colchicine are contraindicated, not tol...
    Medical condition: Treatment and prevention of gout flares in patients with frequent flares and for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective
    Disease: Version SOC Term Classification Code Term Level
    12.0 10018627 Gout LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) LT (Completed) SE (Completed) EE (Completed) BE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017802-35 Sponsor Protocol Number: CACZ885H2357 Start Date*: 2010-03-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not to...
    Medical condition: Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018627 Gout LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) LV (Completed) EE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001191-30 Sponsor Protocol Number: RDEA594-401 Start Date*: 2017-09-27
    Sponsor Name:Ironwood Pharmaceuticals, Inc.
    Full Title: A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lesinurad 200 mg in Combination With a Xanthine Oxidase Inhibitor (XOI), Compared W...
    Medical condition: Gout and moderate renal impairment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-024172-26 Sponsor Protocol Number: CACZ885H2358 Start Date*: 2011-08-08
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, double-dummy, active controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares, for whom NSAIDs and/or col...
    Medical condition: treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10018627 Gout PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (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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