Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

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The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP, also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo combination as an anti-pyretic agent.

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Detailed Description

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N-acetyl-p-aminophenol (APAP), or more commonly known as acetaminophen in the United States, accounts for more overdose and overdose deaths in the United States and United Kingdom than any other pharmaceutical agent. If N-acetylcysteine (NAC) is given within 8 to 10 hours of APAP ingestion, it has been shown to prevent serious liver failure and death in the setting of overdoses. Therefore, it may be beneficial to administer APAP in combination with NAC routinely to reduce rates of liver failure and death. Because NAC's main role is to reduce the accumulation of APAP's toxic metabolites, the concomitant administration of NAC should have no impact on the efficacy of APAP as an antipyretic and analgesic. Thus, we propose a single-center, non-inferiority randomized control study comparing the efficacy of the APAP-NAC combination as compared to APAP-placebo as an anti-pyretic agent.

Conditions

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Liver Failure Liver Failure, Acute Drug Induced Liver Injury Prevention & Control Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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APAP and NAC combination

N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill

Group Type EXPERIMENTAL

APAP and NAC combination

Intervention Type DRUG

APAP 650mg and NAC 600mg combination oral tablet administered once

APAP and Placebo combination

N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill

Group Type PLACEBO_COMPARATOR

APAP and Placebo

Intervention Type DRUG

APAP 650mg and Placebo combination oral tablet administered once

Interventions

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APAP and NAC combination

APAP 650mg and NAC 600mg combination oral tablet administered once

Intervention Type DRUG

APAP and Placebo

APAP 650mg and Placebo combination oral tablet administered once

Intervention Type DRUG

Other Intervention Names

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APAP: n-acetyl-p-aminophenol; acetaminophen; Tylenol NAC: n-acetylcysteine; Mucomyst APAP: n-acetyl-p-aminophenol; acetaminophen; Tylenol

Eligibility Criteria

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Inclusion Criteria

* adults aged 18 to 75 years old
* admitted to an inpatient unit at Columbia-Presbyterian Medical Center
* fever defined as an oral temperature of 38.5°C