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Clinical trials for Fomepizole

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
    Study title: "Benitez JG, Swanson-Biearman B, Krenzelok EP. Nystagmus secondary to fomepizole administration in a pediatric patient. J Toxicol Clin Toxicol. 2000;38(7):795-8. " "Benitez JG, Swanson-Biearman B, Krenzelok EP. Nystagmus secondary to fomepizole administration in a pediatric patient. J Toxicol Clin Toxicol. 2000;38(7):795-8. "
    Active substance: FOMEPIZOLE
    Study summary document link (including results):
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    Document reference: 28471
    Study title: "Brown MJ, Shannon MW, Woolf A, Boyer EW. Childhood methanol ingestion treated with fomepizole and hemodialysis. Pediatrics. 2001 Oct;108(4):E77. " "Brown MJ, Shannon MW, Woolf A, Boyer EW. Childhood methanol ingestion treated with fomepizole and hemodialysis. Pediatrics. 2001 Oct;108(4):E77. "
    Active substance: FOMEPIZOLE
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    Document reference: 28470
    Study title: "Bucaretchi F, Baracat EC. [Acute toxic exposure in children: an overview] J Pediatr (Rio J). 2005 Nov;81(5 Suppl):S212-22. Review. Portuguese. " "Bucaretchi F, Baracat EC. [Acute toxic exposure in children: an overview] J Pediatr (Rio J). 2005 Nov;81(5 Suppl):S212-22. Review. Portuguese. "
    Active substance: FOMEPIZOLE
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    Document reference: 28467
    Study title: "Calello DP, Osterhoudt KC, Henretig FM.New and novel antidotes in pediatrics.Pediatr Emerg Care. 2006 Jul;22(7):523-30. Review. Erratum in: Pediatr Emerg Care. 2007 Feb;23(2):82. " "Calello DP, Osterhoudt KC, Henretig FM.New and novel antidotes in pediatrics.Pediatr Emerg Care. 2006 Jul;22(7):523-30. Review. Erratum in: Pediatr Emerg Care. 2007 Feb;23(2):82. "
    Active substance: FOMEPIZOLE
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    Document reference: 28466
    Study title: "Caravati EM, Heileson HL, Jones M. Treatment of severe pediatric ethylene glycol intoxication without hemodialysis. J Toxicol Clin Toxicol. 2004;42(3):255-9. " "Caravati EM, Heileson HL, Jones M. Treatment of severe pediatric ethylene glycol intoxication without hemodialysis. J Toxicol Clin Toxicol. 2004;42(3):255-9. "
    Active substance: FOMEPIZOLE
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    Document reference: 28469
    Study title: "Casavant MJ. Fomepizole in the treatment of poisoning. Pediatrics. 2001 Jan;107(1):170. " "Casavant MJ. Fomepizole in the treatment of poisoning. Pediatrics. 2001 Jan;107(1):170. "
    Active substance: FOMEPIZOLE
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    Document reference: 28472
    Study title: "De Brabander N, Wojciechowski M, De Decker K, De Weerdt A, Jorens PG. Fomepizole as a therapeutic strategy in paediatric methanol poisoning. A case report and review of the literature. Eur J Pediatr. 2005 Mar;164(3):158-61. Epub 2004 Dec 1. Review. " "De Brabander N, Wojciechowski M, De Decker K, De Weerdt A, Jorens PG. Fomepizole as a therapeutic strategy in paediatric methanol poisoning. A case report and review of the literature. Eur J Pediatr. 2005 Mar;164(3):158-61. Epub 2004 Dec 1. Review. "
    Active substance: FOMEPIZOLE
    Study summary document link (including results):
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    Document reference: 28468
    Study title: "Harry P, Jobard E, Briand M, Caubet A, Turcant A. Ethylene glycol poisoning in a child treated with 4-methylpyrazole. Pediatrics. 1998 Sep;102(3):E31. " "Harry P, Jobard E, Briand M, Caubet A, Turcant A. Ethylene glycol poisoning in a child treated with 4-methylpyrazole. Pediatrics. 1998 Sep;102(3):E31. "
    Active substance: FOMEPIZOLE
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    Document reference: 28475
    Study title: "Shannon M. Toxicology reviews: fomepizole--a new antidote. Pediatr Emerg Care. 1998 Apr;14(2):170-2. " "Shannon M. Toxicology reviews: fomepizole--a new antidote. Pediatr Emerg Care. 1998 Apr;14(2):170-2. "
    Active substance: FOMEPIZOLE
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    Document reference: 28476
    Study title: "Tenenbein M. Recent advancements in pediatric toxicology. Pediatr Clin North Am. 1999 Dec;46(6):1179-88, vii. Review. " "Tenenbein M. Recent advancements in pediatric toxicology. Pediatr Clin North Am. 1999 Dec;46(6):1179-88, vii. Review. "
    Active substance: FOMEPIZOLE
    Study summary document link (including results):
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    Document reference: 28473
    Study title: "Wiley JF 2nd. Novel therapies for ethylene glycol intoxication. Curr Opin Pediatr. 1999 Jun;11(3):269-73. Review. " "Wiley JF 2nd. Novel therapies for ethylene glycol intoxication. Curr Opin Pediatr. 1999 Jun;11(3):269-73. Review. "
    Active substance: FOMEPIZOLE
    Study summary document link (including results):
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    Document reference: 28474
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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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