Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 567
- 试验地点
- 26
- 主要终点
- "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
研究概览
简要总结
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
详细描述
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
- •clinical diagnosis of OA of the knee 1 year or longer,
- •subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,
- •subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.
排除标准
- •subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
- •subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
- •subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
- •Other protocol-specific inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Buprenorphine transdermal system 10 and 20 applied for 7-day wear
干预措施: Buprenorphine (Drug)
2
Placebo transdermal system to match BTDS patches, applied for 7-day wear
干预措施: Placebo (Drug)
结局指标
主要结局
"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
时间窗: 24 hours (week 12)
"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.
次要结局
- Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.(10 weeks)
- Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.(Weeks 4, 8, and 12 of the double-bind phase)