An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 13
- 主要终点
- Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
研究概览
简要总结
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
详细描述
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic 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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
- •Weigh at least 50 kg
- •Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
排除标准
- •Have a life expectancy <4 weeks
- •Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
- •Have dysphagia or difficulty swallowing whole tablets
- •Have a previous exposure to oxymorphone
- •Have an ileostomy
研究组 & 干预措施
Oxymorphone ER
干预措施: Oxymorphone ER (Drug)
结局指标
主要结局
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
时间窗: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
次要结局
- Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues(Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period))
- Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken(Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period))
- Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose(Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period))
- Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses(Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period))