跳至主要内容
临床试验/NCT00400621
NCT00400621已完成4 期

Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen:

Denver Health and Hospital Authority0 个研究点目标入组 150 人开始时间: 2003年4月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
150
主要终点
mean change in serum ALT between treatment groups

研究概览

简要总结

The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
Double

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

mean change in serum ALT between treatment groups

次要结局

  • proportion of patients that developed an abnormal ALT
  • proportion of patients that developed hepatoxicity (ALT>1000 IU>L)
  • proportion of patients that developed drug induced liver injury

研究者

申办方类型
Other

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