NCT00324038已完成4 期
An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Average Daily Pain Scores - BS11 Pain Scores.
研究概览
简要总结
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either sex aged 65 or above
- •Diagnosis of OA of the hip and/or knee
- •Severe pain requiring step two medication
- •Taking maximum dose of paracetamol
排除标准
- •Painful disease of the joints other than OA
- •Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
- •Subjects taking cyclooxygenase (COX) II selective inhibitors
研究组 & 干预措施
buprenorphine transdermal system
Experimental
Buprenorphine transdermal 7 day analgesic patch
干预措施: Buprenorphine (Drug)
codeine paracetamol tablets
Active Comparator
codeine paracetamol combination tablets
干预措施: Codeine paracetamol (Drug)
结局指标
主要结局
Average Daily Pain Scores - BS11 Pain Scores.
时间窗: every day over a 12 week study duration.
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
次要结局
未报告次要终点
研究者
研究点 (1)
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