Clinical TrialID 7291
Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
NCT05517668
Acetaminophen|Drug Overdose|Acetaminophen Overdose|Acetaminophen Poisoning|Drug-induced Liver Injury|Liver Failure|Liver Toxicity
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7291
- Evidence Id
- 7291
- Core Evidence Id
- 7291
- Source Clinical Trial Id
- 7282
- Herb2 Clinical Trial Id
- HBCT007282
- Nct Id
- NCT05517668
- Title
- Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
- Status
- Recruiting
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Acetaminophen|Drug Overdose|Acetaminophen Overdose|Acetaminophen Poisoning|Drug-induced Liver Injury|Liver Failure|Liver Toxicity
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Intravenous infusion of N-acetylcysteine|DRUG: Intravenous infusion of Fomepizole (4-MP)
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult, Older_Adult
- Enrollment
- 40
- Outcome Measure
- Difference in serum ALT from presentation to peak recorded ALT, Determine the effect of fomepizole on the severity of acute liver injury in patients with acetaminophen ingestion. Serum ALT is a recognized measure of liver injury. A smaller increase in ALT indicates the efficacy of the study drug., ALT will be measured at baseline, then at 12, 20, 32, 44, etc. hours after starting NAC (and every 12 hours afterwards) as long as patient is receiving medication (either NAC or NAC and 4-MP), two to three days on average.
- Sponsor Collaborator
- Richard Dart, MD, PhD|Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Funded By
- OTHER
- Location
- Denver Health and Hospital Authority, Denver, Colorado, 80204, United States
- Other Id
- 21-4745|160034
- Start Date
- 2022-09-12
- Primary Completion Date
- 2025-08-31
- Completion Date
- 2025-11-30
- First Posted
- 2022-08-26
- Results First Posted
- Last Update Posted
- 2024-02-20
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05517668
- Title Cn
- Title En
- Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
- Bilingual Status
- semi_complete