NCT00446069已完成2 期
A Double-blind, Randomized, 2-way Cross-over, Phase II, Efficacy Trial in Cancer Patients to Assess the Overall Efficacy, Patient Preference, Morphine Related Side Effect Profile and Safety of the Egalet® Controlled Release Morphine Formulation 30-240 mg Once Daily Compared to MST Continus® 15-120 mg Twice Daily After 2 Weeks of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Use of rescue medication
研究概览
简要总结
The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase.
- •The patient has opioid-sensitive pain caused by active cancer.
- •The patient is aged minimum 18 years.
排除标准
- •The patient has a life expectancy less than 2 months.
- •The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase
- •Patients with medical conditions contraindicating morphine treatment
- •The patient has hepatic disease or impaired kidney function
- •The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline.
- •The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.
研究组 & 干预措施
Egalet® morphine
Experimental
干预措施: Morphine Sulphate (Drug)
MST Continus®
Active Comparator
干预措施: Morphine Sulphate (Drug)
结局指标
主要结局
Use of rescue medication
时间窗: 2 weeks treatment
次要结局
- Pain intensity(2 weeks treatment)
研究者
研究点 (8)
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