An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 922
- 试验地点
- 95
- 主要终点
- The Number of Participants With Adverse Events as a Measure of Safety
研究概览
简要总结
The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Hydrocodone bitartrate (HYD) once daily (q24h) tablets
干预措施: Hydrocodone bitartrate q24h film-coated tablets (Drug)
结局指标
主要结局
The Number of Participants With Adverse Events as a Measure of Safety
时间窗: Up to 84 weeks
Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.
Daily "Average Pain Over the Last 24 Hours"
时间窗: Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)
"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
- "Pain Right Now" Score(Week 12)
- Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)(Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period)
- Brief Pain Inventory Short Form (BPI-SF)(Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period)
- Medical Outcomes Study 36-item Short Form (SF-36)(Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period)
- Patient Global Impression of Change (PGIC)(At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period)
- Treatment Satisfaction Questionnaire (TSQ) - Part I(At Week 52 or upon early discontinuation at or before Week 4 in the Core Study maintenance period)
- Treatment Satisfaction Questionnaire (TSQ) - Part II(At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension)