Fomepizole for Acetaminophen Overdose
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking certain substances like acetone, cimetidine, or high dosage iron preparations. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Fomepizole for acetaminophen overdose?
Research suggests that Fomepizole, when used alongside N-acetylcysteine (NAC), may help in cases of severe acetaminophen overdose by blocking harmful pathways and reducing liver and kidney damage. Case studies and animal research indicate it could be beneficial, especially when NAC alone is less effective.12345
Is fomepizole safe for use in humans?
Fomepizole has been shown to have an excellent safety profile in humans, particularly when used for methanol and ethylene glycol poisoning, and it has been used safely in cases of acetaminophen overdose as well. It has been reported to prevent liver and kidney damage in animal studies and has been used successfully in both adults and children with acetaminophen toxicity.23456
How is the drug combination of fomepizole and N-acetylcysteine unique for treating acetaminophen overdose?
The combination of fomepizole and N-acetylcysteine (NAC) is unique because fomepizole can extend the treatment window and provide additional protection against liver and kidney damage in severe or late-presenting acetaminophen overdoses. Fomepizole works by blocking harmful metabolic pathways and reducing oxidative stress, which NAC alone may not fully address in such cases.23456
What is the purpose of this trial?
This study is a randomized, placebo-controlled double-blinded clinical trial of patients presenting with acetaminophen poisoning who are at increased risk of developing liver injury. With this trial the investigators are hoping to show the superiority of acetylcysteine (NAC) + fomepizole (4-MP) compared to treatment with acetylcysteine alone. The primary objective of this trial is to determine the effect of fomepizole on the severity of acute liver injury in patients with acetaminophen poisoning.
Research Team
Richard Dart, MD, PhD
Principal Investigator
Rocky Mountain Poison and Drug Safety, division of Denver Health and Hospital Authority
Eligibility Criteria
This trial is for people aged 10 or older who have taken too much acetaminophen and are at risk of liver injury. They must have a certain level of acetaminophen in their blood and be admitted to the hospital. Pregnant women, those with severe liver damage, recent seizures, heart issues, or other serious health problems can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive acetylcysteine and either fomepizole or placebo for acetaminophen overdose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fomepizole (4-MP)
- N-acetylcysteine
Fomepizole (4-MP) is already approved in United States, European Union, Canada for the following indications:
- Ethylene glycol poisoning
- Methanol poisoning
- Ethylene glycol poisoning
- Methanol poisoning
- Ethylene glycol poisoning
- Methanol poisoning
Find a Clinic Near You
Who Is Running the Clinical Trial?
Richard Dart, MD, PhD
Lead Sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Industry Sponsor