A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Overall complete spontaneous bowel movement (CSBM) responder rates
研究概览
简要总结
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC 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
Oxycodone/Naloxone controlled-release tablets (OXN)
干预措施: Oxycodone/Naloxone controlled-release (Drug)
OXY
Oxycodone HCl controlled-release tablets (OXY)
干预措施: Oxycodone HCl controlled-release (Drug)
Placebo
Placebo tablets to match OXN or OXY
干预措施: Placebo (Drug)
结局指标
主要结局
Overall complete spontaneous bowel movement (CSBM) responder rates
时间窗: Weeks 1 through 12
The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY
次要结局
- CSBM Responder at least 50% of the weeks in the double-blind period(Weeks 1 through 12)
- Laxative-free Responder at least 50% of the weeks in the double-blind period(Weeks 1 through 12)