NCT00105937已完成3 期
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Cephalon85 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年4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
- 300
- 试验地点
- 85
- 主要终点
- Tolerability and safety of OraVescent fentanyl when used long-term
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
详细描述
The objective of this study is to determine the tolerability and safety 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
- •18-80 years of age
- •Average of 1-4 breakthrough pain episodes per day
- •Opioid tolerant
- •Histologically documented diagnosis of a malignant solid tumor or hematological malignancy
排除标准
- •Primary breakthrough pain is not related to cancer in any way
- •Opioid or fentanyl intolerance
- •Chronic obstructive pulmonary disease (COPD) or heart disease
- •Sleep apnea or active brain metastases with increased cranial pressure
结局指标
主要结局
Tolerability and safety of OraVescent fentanyl when used long-term
次要结局
- Assess the effectiveness of OraVescent fentanyl
- Assess the development of incremental tolerance
研究者
研究点 (85)
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