A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 5
- 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 objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.
Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
- •Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.
排除标准
- •Subjects who have pain or disability in a site other than the operative joint.
- •Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
- •Subjects whose body mass index (BMI) is 40 or more.
研究组 & 干预措施
BTDS 10
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
干预措施: Buprenorphine transdermal patch (Drug)
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
干预措施: Buprenorphine transdermal patch (Drug)
BTDS 30
Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear
干预措施: Buprenorphine transdermal patch (Drug)
Placebo TDS
Placebo patches were similar to BTDS 10 and 20.
干预措施: Placebo BTDS (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) as a Measure of Safety
时间窗: From signed informed consent to 7 days after end of study (approx. 35 days)
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
次要结局
未报告次要终点