Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 418
- 试验地点
- 23
- 主要终点
- "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
研究概览
简要总结
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release 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, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
详细描述
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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
- 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
- •Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
- •Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
排除标准
- •Not currently taking and tolerating opioids.
- •Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
- •Requiring frequent analgesic therapy for chronic condition(s), 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 (Drug)
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
干预措施: Buprenorphine (Drug)
Oxycodone Immediate-Release (Oxy IR) 40 mg
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
干预措施: oxycodone immediate-release (Drug)
结局指标
主要结局
"Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
时间窗: Weeks 4, 8, and 12 of the double-blind phase
The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
次要结局
- The Mean Daily Number of Supplemental Analgesic Medication Tablets(Double-blind phase (84 days))
- The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase(Weeks 4, 8 and 12 of the double-blind phase)
- The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase(Weeks 4, 8, and 12 of the Double-blind Phase)