An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 11
- 主要终点
- Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet
研究概览
简要总结
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).
This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
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
- 是
入选标准
- •Male or female > 12 to 17 years of age, inclusive
- •Weigh at least 50 kg
- •Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
- •Are expected to be hospitalized for the duration of the study
排除标准
- •Known allergy to, or a significant reaction to, oxymorphone or another opioid
- •Life expectancy of < 4 weeks
- •Positive pregnancy test at screening
研究组 & 干预措施
Oxymorphone IR
Open-Label, 2 part ascending-dose multicenter study
干预措施: Oxymorphone IR (Drug)
结局指标
主要结局
Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet
时间窗: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination
Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
Subjects Taking Rescue Medication
时间窗: first dose through 48 hours after first dose
Percentages are based on the number of subjects in each treatment group.
次要结局
- AUC(0-t) of Single Dose of Oxymorphone by Treatment Group(Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h)
- AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group(Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h)
- Cmax of Single Dose of Oxymorphone by Treatment Group(Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h)
- Tmax of Single Dose of Oxymorphone by Treatment Group(Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h)
- Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group(Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h)
- Terminal Half-life of Single Dose of Oxymorphone by Treatment Group(Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h)