NCT01431742撤回3 期
An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain
BioDelivery Sciences International0 个研究点开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Mean change in pain intensity
研究概览
简要总结
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 low back 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 low back pain for ≥3 months with a pain intensity ≥5 [11 point NRS] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks
- •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
Experimental
buprenorphine buccal soluble film
干预措施: BEMA Buprenorphine (Drug)
结局指标
主要结局
Mean change in pain intensity
时间窗: Baseline up to approximately Week 52
The average of the visit pain scores for Baseline up to approximately Week 52
次要结局
未报告次要终点
研究者
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