An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 19
- 主要终点
- Number of Participants With Adverse Events (AEs) as a Measure of Safety.
研究概览
简要总结
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
详细描述
Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 of either sex aged 18 years or older.
- •Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.
排除标准
- •Subjects currently receiving daily morphine or oxycodone (mono-therapy).
- •Subjects who are discontinued from BUP3201 due to adverse events.
- •Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.
- •Refer to core study for additional inclusion/exclusion information.
研究组 & 干预措施
BTDS 5, 10 or 20
Buprenorphine transdermal patch
干预措施: Buprenorphine transdermal patch (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
时间窗: 28 weeks
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
次要结局
未报告次要终点