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This study has been withdrawn prior to enrollment.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:
Columbia University
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
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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:
|
|
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
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 Body Temperature Changes Signs and Symptoms Hepatic Insufficiency Liver Diseases Digestive System Diseases Poisoning Substance-Related Disorders Acetaminophen Acetylcysteine N-monoacetylcystine Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013