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

This study has been withdrawn prior to enrollment.
(Unable to recruit sufficient participants due to lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Matthew Chang, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01137591
First received: June 3, 2010
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Liver Failure
Liver Failure, Acute
Drug Induced Liver Injury
Prevention & Control
Fever
Drug: APAP and NAC combination
Drug: APAP and Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acetaminophen in Combination With N-Acetylcysteine (NAC) vs. Placebo in the Treatment of Fever: A Double-Blind, Randomized Control Study

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo [ Time Frame: 6 hours after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Within 24 hours of study drug administration ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: July 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APAP and NAC combination
N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill
Drug: APAP and NAC combination
APAP 650mg and NAC 600mg combination oral tablet administered once
Other Names:
  • APAP: n-acetyl-p-aminophenol; acetaminophen; Tylenol
  • NAC: n-acetylcysteine; Mucomyst
Placebo Comparator: APAP and Placebo combination
N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill
Drug: APAP and Placebo
APAP 650mg and Placebo combination oral tablet administered once
Other Name: APAP: n-acetyl-p-aminophenol; acetaminophen; Tylenol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137591

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Matthew Chang, MD Columbia University
  More Information

Additional Information:
Publications:
Responsible Party: Matthew Chang, MD, Assistant Clinical Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01137591     History of Changes
Other Study ID Numbers: AAAD4090(Y2M01)
Study First Received: June 3, 2010
Last Updated: February 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Acetaminophen
Acetylcysteine
Antidotes

Additional relevant MeSH terms:
Fever
Liver Failure
Liver Failure, Acute
Drug-Induced Liver Injury
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Acetaminophen
Acetylcysteine
N-monoacetylcystine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers

ClinicalTrials.gov processed this record on August 18, 2014