NCT00402571已完成4 期
Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 4
- 主要终点
- mean change in serum aminotransferase levels between study groups
研究概览
简要总结
The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient, regardless of gender or ethnicity, who was:
- •18 years or older
- •admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
- •signed a written informed consent form.
- •Patients were excluded from the study at baseline if any of the following were present:
- •serum acetaminophen level greater than 20 mcg/ml
- •serum AST or ALT levels greater than 200 IU/L
- •INR greater than 1.5
- •if female, positive for beta-subunit of chorionic gonadotropin
- •clinically intoxicated, psychiatrically impaired or unable to give informed consent
- •known hypersensitivity to acetaminophen
- •history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
- •currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
排除标准
- 未提供
结局指标
主要结局
mean change in serum aminotransferase levels between study groups
次要结局
- proportion of subjects tht developed an abnormal aminotransferase level
- proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L)
- proportion of subjects that developed drug induced liver injury
研究者
研究点 (4)
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