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Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose

NCT05517668 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-11-25

No results posted yet for this study

Summary

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.

Conditions

  • Acetaminophen
  • Drug Overdose
  • Acetaminophen Overdose
  • Acetaminophen Poisoning
  • Drug-induced Liver Injury
  • Liver Failure
  • Liver Toxicity

Interventions

DRUG

Intravenous infusion of N-acetylcysteine

If randomized to Control, the participant will receive only N-acetylcysteine. The dose will be determined by the site investigator. Typical continued infusion rate is 6.25 mg/kg/hr. The control drug (D5W) will be administered using the same schedule as fomepizole.

DRUG

Intravenous infusion of Fomepizole (4-MP)

If randomized to fomepizole, the proposed infusion schedule for fomepizole closely mirrors the dosing outlined in the medication's package insert. Specifically, the Antizol (fomepizole) doses (bags) #1-5 allocated for the study will precisely adhere to the manufacturer's recommendations from the package insert. This entails an initial loading dose of 15 mg/kg followed by four subsequent doses of 10 mg/kg. The dose of fomepizole will not be adjusted based on age, presence of liver injury or renal insufficiency.

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

    collaborator INDUSTRY

  • Richard Dart, MD, PhD

    lead OTHER

Principal Investigators

  • Richard Dart, MD, PhD · Rocky Mountain Poison and Drug Safety, division of Denver Health and Hospital Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2025-10-31
Completion
2025-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05517668 on ClinicalTrials.gov