ACTRN12622000723785尚未招募2 期
Phase IIa randomized, placebo-controlled, double-blind crossover pilot study of tolerability and efficacy of cannabidiol (CBD) and palmitoylethanolamide (PEA) applied to the skin for the relief of osteoarthritic joint pain.
Westmead Hospital0 个研究点目标入组 72 人开始时间: 2022年5月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
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
- 30 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1. Diagnosis of OA defined by X-ray evidence of joint damage;
- •2. Age 30–90;
- •3. Disease duration of 2 years or more;
- •4. Continued pain in any of the knee, hip, hands or lower lumbar spine joints despite oral
- •medications;
- •5. No previous use of oral or smoked cannabinoids for pain management; able to complete
- •questionnaire;
- •6. Able to attend outpatient clinic at monitoring and follow-up time points.
排除标准
- •1. History of psychiatric disorder;
- •2. History of drug dependency;
- •3. Known sensitivity to cannabinoid agents;
- •4. History of epilepsy; patient pain explained by fibromyalgia;
- •5. Recurrent or recent malignancy;
- •6. Pregnancy or breastfeeding;
- •7. Change of pain medication in the preceding 4 weeks;
- •8. Severe renal or liver dysfunction (patient excluded if there is an elevation of baseline liver enzymes);
- •9. Concomitant medications: Prior or current cannabis use; current use of valproate, clobazam, topiramate, and/or rufinamide.
研究者
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