Trials / Withdrawn
WithdrawnNCT01137591
Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever
Acetaminophen in Combination With N-Acetylcysteine (NAC) vs. Placebo in the Treatment of Fever: A Double-Blind, Randomized Control Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Columbia University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APAP and NAC combination | APAP 650mg and NAC 600mg combination oral tablet administered once |
| DRUG | APAP and Placebo | APAP 650mg and Placebo combination oral tablet administered once |
Timeline
- Start date
- 2009-04-01
- First posted
- 2010-06-04
- Last updated
- 2015-03-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01137591. Inclusion in this directory is not an endorsement.