NCT01045603已完成不适用
A 3 Month Observational Prospective Patient Cohort Study of the Treatment of Breakthrough Pain in Cancer Patients With Instanyl®
Takeda1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2009年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Success of titration (Y/N), defined as reaching a maintenance dose
研究概览
简要总结
The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Success of titration (Y/N), defined as reaching a maintenance dose
时间窗: At week 4 and month 3 after baseline
Dose level of Instanyl® after titration, defined as the maintenance dose
时间窗: At week 4 and month 3 after baseline
次要结局
- Adverse Drug Reactions (ADR)(At week 4 and month 3 after baseline)
- Reason and time for Instanyl® termination(At week 4 and month 3 after baseline)
- Change in Instanyl® maintenance dose(At week 4 and month 3 after baseline)
- Change in level of background medication (standardised daily dose)(At week 4 and month 3 after baseline)
- Pain, pain relief and impact of pain of daily life(At baseline and week 4)
- Treatment satisfaction(At baseline and week 4)
研究者
研究点 (1)
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