NCT01206907撤回3 期
AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID
Endo Pharmaceuticals0 个研究点开始时间: 2010年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate 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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 2 to ≤6 years of age, inclusive
- •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 >1 mg/kg qd oral morphine equivalent)
- •Expected to continue to require a strong opioid for pain relief for at least 4 months
- •Able to swallow the oxymorphone HCl immediate-release oral liquid
- •Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements
排除标准
- •Known allergy to, or a significant reaction to, oxymorphone or another opioid
- •Life expectancy <4 months
- •Any clinical condition in the investigator's opinion that would preclude participation
- •Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
- •Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
- •Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
- •An ileostomy
- •Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
- •Investigator anticipates that the subject would be unable to comply with the protocol
- •Parent/legal guardian is unable to complete the subject's daily study medication diary
- •Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
结局指标
主要结局
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
时间窗: bi-weekly for three months in the maintenance phase
次要结局
- Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.(bi-weekly for 3 months in the maintenance phase)
研究者
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