EUCTR2017-002192-25-NL进行中（未招募）1 期
eurotoxic adverse effects of morphine and oxycodone in continuous subcutaneous infusion for treatment of pain in terminal patients with diminished renal function: a Randomized Controlled Trial. - MOSART-study
Center of Expertise in Palliative Care, Maastricht University Medical Centre0 个研究点目标入组 234 人开始时间: 2017年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 234
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
- •- minimal age of 18 years at the time of inclusion;
- •- the subject is in the terminal phase, i.e. death in the near future is expected by the treating physician;
- •- start of CSCI with an opioid for treatment of pain is indicated by the treating physician;
- •- willingness to allow one-time blood collection for assessment of renal function (eGFR);
- •- a signed informed consent is given by the participant or his/her legal representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 234
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 234
排除标准
- •- delirium at the time of inclusion;
- •- opioid induced hyperalgesia (OIH) at the time of inclusion;
- •- a medical necessity to apply a different opioid than morphine or oxycodone, such as previously demonstrated non-response to morphine or oxycodone (defined as a complete absence of any pain reduction after appropriate dosage), previously demonstrated unacceptable side effects of morphine or oxycodone, or a medical indication for an opioid with NMDA-receptor-antagonistic properties (currently only known for methadone);
- •- a documented allergy for morphine or oxycodone.
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