An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 41
- 主要终点
- The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation 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 (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
- •Good, very good or excellent pain control on current opioid therapy.
- •Willing and able to use a telephone interactive voice response service.
排除标准
- •Currently receiving daily morphine or oxycodone monotherapy.
- •Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.
- •Other protocol-specific exclusion/inclusion criteria may apply.
研究组 & 干预措施
BTDS (5, 10 or 20)
Buprenorphine transdermal patch
干预措施: Buprenorphine transdermal patch (Drug)
Placebo to match BTDS
Placebo to match buprenorphine transdermal patch
干预措施: Placebo to match BTDS (Drug)
结局指标
主要结局
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
时间窗: Double-blind phase (14 days)
Ineffective treatment was defined as: * Subject took \>1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
次要结局
- Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment(14 days)
- The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase(14 days)
- The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).(14 days)