NCT00626600终止3 期
An Open, Multi-centre, Non-comparative Observational Study to Assess the Safety and Tolerability of Oxycodone Injection 50 mg/mL as a Subcutaneous Infusion in Patients With Severe Cancer Pain.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
研究概览
简要总结
Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.
详细描述
This is study involving a treatment phase of up to 20 days. During this time patients will receive Oxycodone Hydrochloride 50mg/ml as a subcutaneous infusion. During the treatment phase, safety will be assessed by documentation of type and frequency of spontaneously reported adverse events and adverse events noted after assessment of the infusion site (every 24 hours and when resited). The subjects will be followed up for 7 days to collect information on ongoing AEs/SAEs and any new AEs/SAEs that may have occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18 years and above, who have severe cancer pain.
- •Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively.
- •Subjects who give written informed consent to participate in the study.
- •Subjects who agree to their primary care physician being informed of their participation in the study.
- •Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998.
排除标准
- •Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving and are not using adequate contraception measures.
- •Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients.
- •Subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion.
- •Subjects with neutropenia, thrombocytopenia or coagulation disorders.
- •Subjects with any contraindications to oxycodone as outlined in the Investigator Brochure or Summary Product Information sheet for oxycodone.
- •Subjects who are currently participating in another clinical research study involving a new chemical entity.
- •Subjects whom the Investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.
结局指标
主要结局
To assess the safety and tolerability of Oxycodone hydrochloride injection 50 mg/mL
时间窗: 20 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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