A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 42
- 主要终点
- The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
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 (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
- •an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.
排除标准
- •ingest opioid analgesics on a daily basis.
- •ingest >2500 milligrams (mg) acetaminophen on a daily basis.
- •require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
- •Other protocol-specific exclusion/inclusion criteria may apply.
研究组 & 干预措施
BTDS
Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
干预措施: Buprenorphine transdermal patch (Drug)
Placebo
Placebo to match BTDS 5, 10 or 20 mcg/h
干预措施: Placebo (Drug)
结局指标
主要结局
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
时间窗: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods
Inadequate analgesia: * "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or; * \>1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or; * ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
次要结局
- Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site(7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.)