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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01137591
Other study ID # AAAD4090
Secondary ID
Status Withdrawn
Phase N/A
First received June 3, 2010
Last updated March 3, 2015
Start date April 2009

Study information

Verified date March 2015
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
APAP and NAC combination
APAP 650mg and NAC 600mg combination oral tablet administered once
APAP and Placebo
APAP 650mg and Placebo combination oral tablet administered once

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bronstein AC, Spyker DA, Cantilena LR Jr, Green J, Rumack BH, Heard SE. 2006 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Clin Toxicol (Phila). 2007 Dec;45(8):815-917. — View Citation

Smilkstein MJ, Knapp GL, Kulig KW, Rumack BH. Efficacy of oral N-acetylcysteine in the treatment of acetaminophen overdose. Analysis of the national multicenter study (1976 to 1985). N Engl J Med. 1988 Dec 15;319(24):1557-62. — View Citation

Vale JA, Proudfoot AT. Paracetamol (acetaminophen) poisoning. Lancet. 1995 Aug 26;346(8974):547-52. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 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. Within 24 hours of study drug administration Yes
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