Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 47
- 主要终点
- Number of Participants With Adverse Events (AEs) as a Measure of Safety
研究概览
简要总结
The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.
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
- 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
- •clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
- •taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.
排除标准
- •requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
- •scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
- •Other protocol-specific exclusion/inclusion criteria may apply.
研究组 & 干预措施
BTDS
Buprenorphine transdermal patches 10 or 20 mcg/h
干预措施: Buprenorphine transdermal patch (Drug)
Placebo
Placebo to match buprenorphine transdermal patch 10 or 20
干预措施: Placebo transdermal patch (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) as a Measure of Safety
时间窗: 483 days
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
次要结局
未报告次要终点