A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 24
- 主要终点
- Change in Pain Intensity From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
详细描述
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.
Buprenorphine HCl buccal film 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
- •Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- •Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening 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 at Screening, prior to any procedure being performed
排除标准
- •Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- •Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- •Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- •Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
- •History of long QT syndrome, or an immediate family member with this condition
- •Diagnosis of moderate to severe hepatic impairment.
- •History of severe emesis with opioids
- •Clinically significant sleep apnea
研究组 & 干预措施
BEMA Buprenorphine
buprenorphine buccal soluble film
干预措施: Buprenorphine (Drug)
BEMA Placebo
placebo buccal soluble film
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pain Intensity From Baseline to Week 12
时间窗: Baseline, Week 12
Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale(Baseline, Week 12)
- Change From Baseline to Week 12 in Roland Morris Disability Questionnaire(Baseline, Week 12)
- Use of Rescue Medication(Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase)
- Change From Baseline in Pain Intensity Over Time Using NRS Scale(Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84)
- Number of Participants With Response to Treatment as Assessed by an NRS Scale(Week 12)
- Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)(Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks))
- Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM(Baseline, Week 12)
- Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug(Baseline, Week 12)
- Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug(Baseline, Week 12)