EUCTR2016-000197-38-GB进行中（未招募）1 期
A double blind randomised parallel group trial of paracetamol versus placebo in conjunction with strong opioids for cancer related pain. - Paracetamol with Strong Opioids for cancer pain (PaSO)
niversity of Edinburgh0 个研究点目标入组 280 人开始时间: 2016年7月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age 16 years and over
- •2.Diagnosis of incurable cancer
- •3.Clinician-predicted life expectancy > 2 months
- •4.Anticipated to be clinically stable for duration study involvement
- •5.Receiving daily regular strong opioids
- •6.Able to take study drug/placebo in its current form
- •7. Prescribed and taking paracetamol 1g four times a day
- •8.Average pain >=2 and <=8 in past 24 hours
- •9.Able to provide written informed consent
- •10.Able to complete necessary assessments required as part of the trial
- •11.Average pain score stable (ie maximum range 1 point) for 3 consecutive days prior to randomisation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •1.Pain which the clinician deems to be unstable
- •2.Clinically significant renal or liver disease
- •3.Weight less than 50kg
- •4.Pain is expected to change during the course of the study as a result of oncological or other treatments
- •5.Co-enrolment in other drug trials
- •6.Known to be pregnant or breast-feeding at the time of recruitment
- •7. Previously enrolled in this study
研究者
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