NCT01358526已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,095
- 试验地点
- 142
- 主要终点
- The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
研究概览
简要总结
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
OXN
Experimental
Oxycodone/Naloxone Controlled-release Tablets (OXN)
干预措施: Oxycodone/Naloxone Controlled-release (Drug)
Placebo
Placebo Comparator
Placebo tablets to match OXN
干预措施: Placebo (Drug)
结局指标
主要结局
The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
时间窗: 24 hours (Week 12)
The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.
次要结局
- The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12(Weeks 4, 8, and 12)
- Patient Global Impression of Change (PGIC)(Week 12)
研究者
研究点 (142)
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