A Phase 2B, Open-label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Effectiveness of Hydrocodone Bitartrate Extended-Release Tablets (HYD) in Children, Aged 12 to 17 Years Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Around-the-Clock Opioid Analgesics
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 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 purpose of this study is to evaluate the safety, pharmacokinetics (PK), and effectiveness of Hydrocodone Bitartrate (HYD) tablets in children with moderate to severe pain requiring around-the-clock opioid analgesics.
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
- 12 Years 至 17 Years（Child）
- 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
HYD 20 - 120 mg
Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets administered orally every 24 hours
干预措施: HYD 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 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).
Pharmacokinetic analysis to characterize the apparent volume of distribution (Vc/F) of hydrocodone following oral administration
时间窗: Day 1, End of week 2, End of week 4
Pharmacokinetic analysis to characterize the apparent oral clearance (CL/F) of hydrocodone following oral administration
时间窗: Day 1, End of week 2, End of week 4
次要结局
- "Pain Right Now" Assessment by Patients using 100-mm visual analog scale (VAS)(Day 1 up to week 4)
- Parent/ Caregiver-Assessed Global Impression of Change (PGIC)(Week 4 / end of treatment)