NCT01971632已完成3 期
A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain
Mundipharma Research GmbH & Co KG0 个研究点目标入组 463 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 主要终点
- Efficacy of Analgesia
研究概览
简要总结
The primary objective was to demonstrate the superiority of OXN over placebo over time from the initial dose of study medication to multiple pain events (inadequate analgesia) during the double blind phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
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
研究组 & 干预措施
Oxycodone/Naloxone
Active Comparator
干预措施: Oxycodone & naloxone combination, prolonged release (Drug)
Placebo oxycodone/naloxone
Placebo Comparator
干预措施: placebo oxycodone / naloxone (Drug)
结局指标
主要结局
Efficacy of Analgesia
时间窗: up to 12 weeks
Primary Objective is To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.
次要结局
- Quality of sleep assessment(up to 12 weeks)
- The amount of rescue medication taken(up to 12 weeks)
研究者
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