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临床试验/NCT01137591
NCT01137591撤回不适用

Acetaminophen in Combination With N-Acetylcysteine (NAC) vs. Placebo in the Treatment of Fever: A Double-Blind, Randomized Control Study

Columbia University1 个研究点 分布在 1 个国家开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • if oral temperature cannot be obtained
  • abnormal aminotransferase levels
  • prior adverse reaction to acetaminophen or N-acetylcysteine

研究组 & 干预措施

APAP and NAC combination

Experimental

N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill

干预措施: APAP and NAC combination (Drug)

APAP and Placebo combination

Placebo Comparator

N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill

干预措施: APAP and Placebo (Drug)

结局指标

主要结局

Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo

时间窗: 6 hours after study drug administration

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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