ACTRN12616001618448已完成3 期
Randomised, double-blind, placebo-controlled phase III trial of oral melatonin for the prevention of delirium in hospital in people with advanced cancer
niversity Technology Sydney0 个研究点目标入组 221 人开始时间: 2016年11月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 221
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Aged 18 years or older
- •- English speaking or availability of a health care interpreter.
- •- Diagnosis of advanced cancer (histological or clinical diagnosis) defined by the intent of treatment no longer being curative
- •- Admission to an acute or sub-acute inpatient facility
- •- Participant is able to give fully informed written consent
排除标准
- •- Inability to take medications orally
- •- Delirium on admission as defined the cut off score on the delirium rating scale DRS-R-98 of 17.75 or more indicative of delirium
- •- Australian Karnofsky Performance Status (AKPS) score less than 30 at the beginning of the study
- •- A known allergy to melatonin or placebo content
- •- Active seizure disorder defined as seizure within last one month, or seizure disorder not on anticonvulsants
- •- Concomitant cimetidine use (CYP2D Inhibitor increases melatonin levels by 1.7 fold)
- •- Current history alcohol abuse (alcohol reduces melatonin levels);
- •- In people taking warfarin, a markedly nontherapeutic international normalized ratio (less than 1 or greater than 4)
- •- Moderate to severe dementia as defined by clinical diagnosis of dementia and a Short Blessed Test (SBT) score equal or greater that 10
- •- Severe hepatic impairment (defined as bilirubin at least 2.5 times upper limit of normal; alkaline phosphatase, aspartate transaminase and/or alanine transaminase more than 3 times upper limit of normal clinically determined to be due to hepatic impairment)
- •- Current use of melatonin for other indication, melatonin use within last 14 days
- •- Currently taking agomelatine, or use of agomelatine in the past 7 days
- •- Pregnant or breastfeeding
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