Study Stopped
Unable to recruit sufficient participants due to lack of funding; PI has left the institution.
Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedMarch 5, 2015
March 1, 2015
June 3, 2010
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
APAP and NAC combination
EXPERIMENTALN-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill
APAP and Placebo combination
PLACEBO COMPARATORN-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill
Interventions
APAP 650mg and NAC 600mg combination oral tablet administered once
APAP 650mg and Placebo combination oral tablet administered once
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- if oral temperature cannot be obtained
- abnormal aminotransferase levels
- prior adverse reaction to acetaminophen or N-acetylcysteine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related 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. doi: 10.1080/15563650701754763.
PMID: 18163234BACKGROUNDSmilkstein 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. doi: 10.1056/NEJM198812153192401.
PMID: 3059186BACKGROUNDVale JA, Proudfoot AT. Paracetamol (acetaminophen) poisoning. Lancet. 1995 Aug 26;346(8974):547-52. doi: 10.1016/s0140-6736(95)91385-8. No abstract available.
PMID: 7658783BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Chang, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 4, 2010
Study Start
April 1, 2009
Last Updated
March 5, 2015
Record last verified: 2015-03