A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 主要终点
- Change From Baseline in NRS Pain Intensity
研究概览
简要总结
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.
详细描述
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic pain.
BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.
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
- •Male or non-pregnant and non-nursing female aged 18 or older
- •History of moderate to severe chronic pain:
- •Subjects completing study BUP-301 (low back pain) or
- •Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
- •Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures
- •Female subjects of childbearing potential must be using a recognized effective method of birth control
- •Written informed consent obtained prior to any procedure being performed
排除标准
- •Cancer related pain
- •Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- •Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
- •History of severe emesis with opioids
- •Clinically significant sleep apnea in the judgment of the investigator
研究组 & 干预措施
BEMA Buprenorphine
buprenorphine buccal soluble film
干预措施: BEMA Buprenorphine (Drug)
结局指标
主要结局
Change From Baseline in NRS Pain Intensity
时间窗: Baseline up to approximately Week 52
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.
次要结局
- Patient Global Impression of Change in Pain Intensity(Baseline to Week 28)
- Treatment Satisfaction Questionnaire for Medication/Global Satisfaction(Baseline to Week 28)
- Subjects Overall Satisfaction With Study Drug(Baseline to Week 52)
- Investigator's Overall Satisfaction With Study Drug(Baseline to Week 52)