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

Not Applicable

Withdrawn

• Conditions: Liver Failure; Liver Failure, Acute; Fever; Prevention & Control; Drug Induced Liver Injury
• Interventions: Drug: APAP and Placebo; Drug: APAP and NAC combination

• Registration Number: NCT01137591
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-06-03
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

• if oral temperature cannot be obtained
• abnormal aminotransferase levels
• prior adverse reaction to acetaminophen or N-acetylcysteine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APAP and Placebo combination	APAP and Placebo	N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill
APAP and NAC combination	APAP and NAC combination	N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill

Primary Outcome Measures

Name	Time	Method
Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo	6 hours after study drug administration

Secondary Outcome Measures

Name	Time	Method
Difference in liver function tests after study drug administration between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo	Within 24 hours of study drug administration	Change in serum total protein (TP), albumin (Alb), total bilirubin (TB), direct bilirubin (DB), amino alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatate (AP) levels before and after the study drug administration.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States