Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
2017年1月12日 更新者：BioDelivery Sciences International
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
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
334
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35209
- Alabama Orthopaedic Center - Research
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Mobile、Alabama、美国、36608
- Coastal Clinical Research, Inc.
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Arizona
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Phoenix、Arizona、美国、85023
- Arizona Research Center
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California
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Fresno、California、美国、93710
- Neuro-Pain Medical Center
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La Jolla、California、美国、92037
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
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Long Beach、California、美国、90806
- Collaborative Neuroscience Network, Inc.
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Florida
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DeLand、Florida、美国、32720
- Avail Clinical Research, LLC
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Jupiter、Florida、美国、33458
- Health Awareness, Inc.
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Plantation、Florida、美国、33317
- Gold Coast Research, LLC
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Port Orange、Florida、美国、32129
- Accord Clinical Research, LLC
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Georgia
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Marietta、Georgia、美国、30060
- Taylor Research, LLC
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Illinois
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Bloomington、Illinois、美国、61701
- Millennium Pain Center
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Indiana
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Evansville、Indiana、美国、47714
- MediSphere Medical Research Center, LLC
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Kansas
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Leawood、Kansas、美国、66211
- International Clinical Research Institute
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Massachusetts
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Watertown、Massachusetts、美国、02472
- MedVadis Research Corporation
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Nevada
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Las Vegas、Nevada、美国、89144
- Office of Stephen H. Miller, MD
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New York
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New York、New York、美国、10022
- Research Across American
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North Carolina
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Raleigh、North Carolina、美国、27612
- Wake Research Associates, LLC
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Winston-Salem、North Carolina、美国、27103
- The Center for Clinical Research, LLC
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Pennsylvania
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Altoona、Pennsylvania、美国、16602
- Allegheny Pain Management
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Texas
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Austin、Texas、美国、78731
- FutureSearch Trials of Neurology
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El Paso、Texas、美国、79902
- Southwest Urgent Care Center
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Utah
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Salt Lake City、Utah、美国、84106
- Lifetree Clinical Research
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West Jordan、Utah、美国、84088
- Advanced Clinical Research
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：BEMA 丁丙诺啡
丁丙诺啡口溶膜
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buccal soluble film; applied to the buccal mucosa twice daily
其他名称：
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安慰剂比较：BEMA Placebo
placebo buccal soluble film
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buccal soluble film; applied to the buccal mucosa twice daily
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Pain Intensity From Baseline to Week 12
大体时间：Baseline, Week 12
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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).
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Baseline, Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Roland Morris 残疾问卷从基线到第 12 周的变化
大体时间：基线，第 12 周
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受试者使用由 24 项残疾陈述组成的 Roland Morris 残疾问卷 (RMDQ) 评估因背痛引起的残疾。
RMDQ 的分数是检查项目的总数，范围从 0 到 24，分数越高表示残疾程度越高。
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基线，第 12 周
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Change From Baseline in Pain Intensity Over Time Using NRS Scale
大体时间：Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
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Change in pain intensity = average of daily pain scores from the last 7 days prior to each 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).
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Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
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Number of Participants With Response to Treatment as Assessed by an NRS Scale
大体时间：Week 12
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Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
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Week 12
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Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
大体时间：Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
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Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
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Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
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Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
大体时间：Baseline, Week 12
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Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
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Baseline, Week 12
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Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
大体时间：Baseline, Week 12
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The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction.
Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
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Baseline, Week 12
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Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
大体时间：Baseline, Week 12
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Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
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Baseline, Week 12
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Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
大体时间：Baseline, Week 12
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Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
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Baseline, Week 12
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Use of Rescue Medication
大体时间：Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
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Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
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Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Andrew Finn, PharmD、BioDelivery Sciences International, Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2011年7月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2010年12月7日
首先提交符合 QC 标准的
2010年12月7日
首次发布 (估计)
2010年12月8日
研究记录更新
最后更新发布 (实际的)
2017年2月27日
上次提交的符合 QC 标准的更新
2017年1月12日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.