NCT02716857已完成3 期
A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet® Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back 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
- 549
- 试验地点
- 74
- 主要终点
- Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.
研究概览
简要总结
The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
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 an English-speaking man or woman between 18 and 75 years of age who has given written informed consent.
- •Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months.
- •Is opioid naïve (ie, taking <20 mg oxycodone/day or opioid equivalent) or is opioid experienced (ie, taking a dose between 20 and 240 mg [inclusive] oxycodone/day or opioid equivalent) for management of moderate-to-severe CLBP at least 14 days prior to screening and will, in the opinion of the investigator, continue to require opioid therapy (between 20 and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe CLBP for the duration of the study.
- •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 and throughout the duration of the study), or is of non-childbearing potential
排除标准
- •Has cancer-related pain.
- •Has a history of receiving >240 mg oxycodone (or equivalent) daily within 30 days before screening.
- •Has a lumbar spinal infusion pump in use or used within 6 months before screening.
- •Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia)
- •Has positive urine drug toxicity screen for illegal or non-prescribed drugs
- •Has current (or history of within the last 5 years prior to screening) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
- •Has positive result for cannabinoids (even if legally prescribed).
- •Has a history of attempted suicide.
研究组 & 干预措施
Oxycodone extended-release
Experimental
Egalet ADER oxycodone tablet
干预措施: Oxycodone extended-release (Drug)
Placebo of Oxycodone extended-release
Placebo Comparator
Egalet ADER oxycodone placebo tablet
干预措施: Placebo of oxycodone extended-release (Drug)
结局指标
主要结局
Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.
时间窗: 16 weeks
次要结局
- Efficacy: daily (past 24 hours) worst pain intensity score (WPI)(16 Weeks)
- Safety: Incidence of TEAEs, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment(16 weeks)
研究者
研究点 (74)
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