NCT01452529已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain
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
- 905
- 试验地点
- 98
- 主要终点
- Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score
研究概览
简要总结
The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen
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
Hydrocodone bitartrate
Experimental
Hydrocodone bitartrate (HYD) once daily (q24h) tablets
干预措施: Hydrocodone bitartrate q24h film-coated tablets (Drug)
Placebo
Placebo Comparator
Placebo to match hydrocodone bitartrate once daily tablets
干预措施: Placebo to match hydrocodone bitartrate q24h tablets (Drug)
结局指标
主要结局
Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score
时间窗: Week 12
Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
次要结局
- Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale(Weeks 4, 8, and 12)
- Patient Global Impression of Change (PGIC)(Week 12)
- Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline(Baseline to Week 12)
- Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline(Baseline to Week 12)
研究者
研究点 (98)
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