A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 660
- 试验地点
- 82
- 主要终点
- Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
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 (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) 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 situations for the relief of moderate to severe 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •low back pain for 3 months or longer, confirmed by radiographic evidence.
- •receiving a stable dose of an opioid analgesic for low back pain.
排除标准
- •taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- •requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.
- •Other protocol-specific exclusion/inclusion criteria may apply.
研究组 & 干预措施
BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
干预措施: Buprenorphine (Drug)
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
干预措施: Buprenorphine (Drug)
Oxycodone Immediate-Release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
干预措施: Oxycodone Immediate-Release (Drug)
结局指标
主要结局
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
时间窗: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
次要结局
- Mean Daily Number of Supplemental Analgesic Tablets(Double-blind phase (84 days))
- Oswestry Disability Index (ODI) Score (V 2.0)(Weeks 4, 8, 12)
- The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.(Weeks 4, 8, 12 of the double-blind phase)