A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 188
- 试验地点
- 61
- 主要终点
- The 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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.
This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
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
- •osteoarthritis of the hip, knee, or spine for 1 year or longer.
- •taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.
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 conditions in addition to osteoarthritis.
- •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 transdermal patch (Drug)
BTDS 20
Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
干预措施: Buprenorphine transdermal patch (Drug)
结局指标
主要结局
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
时间窗: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
次要结局
未报告次要终点