NCT01693328Unknown不适用
A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)
Archimedes Development Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Satisfaction
研究概览
简要总结
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.
• Study objectives include assessment of early treatment satisfaction.
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
- •Adult (aged ≥18 years) with cancer
- •Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain
排除标准
- 未提供
研究组 & 干预措施
PecFent®
干预措施: PecFent® (fentanyl) nasal spray (Drug)
结局指标
主要结局
Satisfaction
时间窗: Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7
Satisfaction will be assessed using a 4-point Likert scale.
次要结局
未报告次要终点
研究者
研究点 (1)
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