A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 20
- 主要终点
- Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
研究概览
简要总结
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
详细描述
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.
- •taking >/=3 opioid doses per day with or without acceptable pain control.
排除标准
- •receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
- •scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.
- •Other protocol-specific exclusion/inclusion criteria may apply.
结局指标
主要结局
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
次要结局
- Brief Pain Inventory
- dropouts due to lack of efficacy
- MOS health survey
- VAS pain intensity
- therapeutic response
- patient preference
- daily patient diary
- and number of oxycodone/acetaminophen or placebo tablets taken