Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 539
- 试验地点
- 24
- 主要终点
- Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
研究概览
简要总结
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
- •Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
- •Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy
排除标准
- •Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
- •Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
- •Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.
- •Other protocol-specific inclusion/exclusion criteria may apply.
研究组 & 干预措施
Double-blind BTDS 10 or 20
Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear
干预措施: Buprenorphine transdermal system (Drug)
Double-blind Placebo TDS
Placebo transdermal system to match BTDS patches, applied for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
时间窗: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
次要结局
- The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase(weeks 2-12)
- The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase(Weeks 4, 8, 12 of double-blind phase)