NCT00345787已完成3 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Osteoarthritic Pain of the Hip or Knee
Mundipharma K.K.1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2006年5月最近更新:
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
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- The time to the development of inadequate analgesia
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.
详细描述
The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males or females ages 40 years or older.
- •Clinical diagnosis of osteoarthritis (OA) of the hip or knee.
排除标准
- •Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).
研究组 & 干预措施
0
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
干预措施: Buprenorphine Transdermal System (Drug)
结局指标
主要结局
The time to the development of inadequate analgesia
时间窗: Up to 12weeks
次要结局
- Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores(12weeks)
研究者
研究点 (1)
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