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临床试验/NCT00626600
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.

Mundipharma Research Limited2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2008年5月最近更新:
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
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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