NCT02603705已完成3 期
An Open-label Phase 3 Trial to Evaluate the Safety and Tolerability of Egalet ADER Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Noncancer Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 281
- 试验地点
- 39
- 主要终点
- Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a man or woman between 18 and 75 years of age.
- •Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months.
- •Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study.
- •Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason.
- •Has stable health, as determined by the investigator.
- •If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening through the duration of the study), or is of non-childbearing potential.
- •Other Criteria Apply
排除标准
- •Has cancer-related pain.
- •Is receiving >240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening.
- •Has a history of attempted suicide.
- •Has used a spinal infusion pump within 6 months before Screening.
- •Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea).
- •Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications).
- •Has positive result for tetrahydrocannabinol (even if legally prescribed).
- •Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
- •Other Criteria Apply
研究组 & 干预措施
Oxycodone extended-release
Experimental
Egalet abuse-deterrent, extended-release oxycodone tablet
干预措施: Oxycodone extended-release (Drug)
结局指标
主要结局
Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment
时间窗: 1 year
次要结局
- Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period(1 year)
研究者
研究点 (39)
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