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Clinical trials for Maltol

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    9 result(s) found for: Maltol. Displaying page 1 of 1.
    EudraCT Number: 2018-000078-31 Sponsor Protocol Number: ST10-01-305 Start Date*: 2025-04-09
    Sponsor Name:Shield TX (UK) Ltd.
    Full Title: Randomised, open-label, active-controlled, multicentre, comparative study to evaluate the safety and efficacy of ferric maltol (iron(III)-maltol complex) (ST10) oral suspension compared to ferrous ...
    Medical condition: Iron deficiency anaemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10022974 Iron deficiency anemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002192-10 Sponsor Protocol Number: ST10-01-103 Start Date*: 2017-02-16
    Sponsor Name:Shield TX (UK) Limited
    Full Title: A phase 1, open label, randomised, repeat dose, parallel group study to evaluate the pharmacokinetics, safety and tolerability of ferric maltol at the three dosage levels in paediatric subjects age...
    Medical condition: Iron deficiency (with or without anaemia)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    20.0 100000012842 10002062 Anaemia iron deficiency LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-005101-39 Sponsor Protocol Number: ORION-LVAD-1 Start Date*: 2018-06-06
    Sponsor Name:Hannover Medical School
    Full Title: A phase IV study to explore the safety of ORal IrON supplementation with ferric maltol in treating iron deficiency in patients with heart failure carrying Left Ventricular Assist Devices (ORION-LVA...
    Medical condition: Patients with iron deficiency anemia and heart failure carrying left ventricular assist devices (LVAD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    20.0 100000004849 10008908 Chronic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-005100-26 Sponsor Protocol Number: ORION-PH-1 Start Date*: 2017-10-09
    Sponsor Name:Hannover Medical School
    Full Title: A pilot Study to explore safety, tolerability and efficacy of ORal IrON supplementation with ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency an...
    Medical condition: Patients with iron deficiency anemia and pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10022974 Iron deficiency anemia LLT
    20.0 100000004855 10037401 Pulmonary hypertensions HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000130-33 Sponsor Protocol Number: ORION-HF Start Date*: 2022-12-23
    Sponsor Name:Hannover Medical School
    Full Title: A pilot study to explore safety, tolerability and efficacy of ORal IrON supplementation with ferric maltol in treating iron deficiency and anaemia in patients with Heart Failure (ORION-HF)
    Medical condition: Patients with heart failure, iron deficiency and anaemia with either reduced or preserved left ventricular ejection fraction
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    20.0 100000004849 10024106 Left heart failure LLT
    20.1 100000004849 10076396 Heart failure with preserved ejection fraction LLT
    20.0 100000004849 10078289 Heart failure with reduced ejection fraction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002496-26 Sponsor Protocol Number: ST10-01-304 Start Date*: 2015-12-02
    Sponsor Name:Shield TX (UK) Ltd.
    Full Title: A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects w...
    Medical condition: Iron deficiency anaemia with inflammatory bowel disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10002062 Anaemia iron deficiency LLT
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2010-023589-39 Sponsor Protocol Number: ST10-01-302 Start Date*: 2012-04-10
    Sponsor Name:Iron Therapeutics (Switzerland) AG
    Full Title: A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ...
    Medical condition: Iron deficiency anaemia in quiescent Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10005329 - Blood and lymphatic system disorders 10002062 Anaemia iron deficiency LLT
    17.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2010-023588-16 Sponsor Protocol Number: ST10-01-301 Start Date*: 2012-04-10
    Sponsor Name:Iron Therapeutics (Switzerland) AG
    Full Title: A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where or...
    Medical condition: Iron deficiency anaemia in quiescent ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10005329 - Blood and lymphatic system disorders 10002062 Anaemia iron deficiency LLT
    17.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2022-000894-16 Sponsor Protocol Number: NL79105.058.22 Start Date*: 2022-05-04
    Sponsor Name:Leiden University Medical Center
    Full Title: Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease
    Medical condition: Inflammatory Bowel Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    20.0 10027433 - Metabolism and nutrition disorders 10022970 Iron deficiency PT
    20.1 10017947 - Gastrointestinal disorders 10021972 Inflammatory bowel disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    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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