NCT00105287已完成3 期
Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Cephalon52 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 52
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
- •Currently taking around the clock opioid therapy for pain
- •Experience on average, 1-4 breakthrough pain episodes per day
排除标准
- •Opioid or fentanyl intolerance
- •Sleep apnea or active brain metastases with increased intracranial pressure
- •COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease
研究者
研究点 (52)
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