ACTRN12610000783022尚未招募不适用
The Efficacy and Tolerability of Cannabis-Based Medicine (Sativex) in the Treatment of Pain and Symptom Burden in End Stage Renal Disease: A double-blind, randomized, placebo-controlled study
orthern Alberta Renal Program0 个研究点目标入组 100 人开始时间: 2010年9月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- All
入选标准
- •1.ESRD on chronic dialysis (greater than or equal to 3 months)
- •2.Moderate to severe daily pain (greater than or equal to 4 on 0-10 Numerical Rating Scale (NRS))
- •a.Receiving no opioids
- •b.Receiving opioids (for at least 14 days prior to the screening visit) but pain not adequately relieved
- •c.If receiving analgesics, no increase in analgesic dose for the past 14 days.
- •3.No cannabinoid use for at least 7 days before screening and during the course of the study
- •4.Stable dry weight for the past 2 weeks
- •5.Have given written, informed consent
排除标准
- •1.No history of myocardial infarction or stroke
- •2.> 3 of the last 6 post hemodialysis blood pressure readings greater than or equal to 160/100 mmHg (or mean arterial pressure (MAP) of 120 mmHg)
- •3.> 3 of the last 6 post hemodialysis blood pressure readings of greater than or equal to 100/55 mmHg (or MAP of 70)
- •4.History of psychosis or psychiatric disorder other than depression
- •5.History or suspicion of substance abuse
- •6.Cancer of the oral cavity
- •7.Scheduled procedures requiring general anesthesia during the study (4 weeks)
- •8.Taking levodopa or the immunosuppressives cyclosporine or tacrolimus
- •9.Known or suspected hypersensitivity to cannabinoids
研究者
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