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Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects

2017年1月12日 更新者：BioDelivery Sciences International

Phase 3, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

815

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

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35215
        • Parkway Medical Center
      • Haleyville、Alabama、美国、35565
        • Haleyville Clinical Research LLC
      • Mobile、Alabama、美国、36608
        • Horizon Research Group. Inc / Alabama Orthopedice
    • Arizona
      • Phoenix、Arizona、美国、85023
        • Arizona Research Center
    • California
      • Anaheim、California、美国、92804
        • Global Research
      • Chino、California、美国、91710
        • Catalina Research Institute, LLC
      • Escondido、California、美国、92025
        • Synergy Clinical Research Center Of Escondido
      • Garden Grove、California、美国、92843
        • RX Clinical Research, Inc.
      • Los Angeles、California、美国、90036
        • Adam D. Karns, MD
    • Connecticut
      • Stamford、Connecticut、美国、06905
        • Stamford Therapeutics Consortium
    • Florida
      • Daytona Beach、Florida、美国、32117
        • Century Clinic Research
      • Deland、Florida、美国、32720
        • Avail Clinical Research, LLC
      • Ft. Lauderdale、Florida、美国、33312
        • Florida Health Center
      • Hialeah、Florida、美国、33013
        • Eastern Research, Inc.
      • Jacksonville、Florida、美国、32257
        • Florida Institute of Medical Research
      • Jupiter、Florida、美国、33458
        • Health Awareness, Inc.
      • Jupiter、Florida、美国、33458
        • Drug Study Institute
      • Kissimmee、Florida、美国、34741
        • FPA Clinical Research
      • Maitland、Florida、美国、32751
        • Try Research, Inc.
      • Naples、Florida、美国、34108
        • NEMA Research, Inc.
      • Orlando、Florida、美国、32806
        • Compass Research, LLC
      • Ormond Beach、Florida、美国、32174
        • Peninsula Research, Inc.
      • Plantation、Florida、美国、33317
        • Gold Coast Research, LLC
      • Port Orange、Florida、美国、32127
        • Progressive Medical Research
      • Tampa、Florida、美国、33603
        • Clinical Research of West Florida, Inc.
      • West Palm Beach、Florida、美国、33409
        • Palm Beach Research Center
      • Winter Park、Florida、美国、32789
        • National Pain Research Institute, LLC
    • Georgia
      • Atlanta、Georgia、美国、30319
        • Atlanta Research Center
      • Blue Ridge、Georgia、美国、30513
        • River Birch Research Alliance, Llc
      • Marietta、Georgia、美国、30060
        • Georgia Institute for Clinical Research, LLC
      • Marietta、Georgia、美国、30060
        • Taylor Research, LLC
      • Marietta、Georgia、美国、30060
        • Drug Studies America
      • Newnan、Georgia、美国、30265
        • Georgia Pain & Spine Care & Better Health Clinical Research
    • Illinois
      • Gurnee、Illinois、美国、60031
        • Clinical Investigations Specialists, Inc.
    • Indiana
      • Evansville、Indiana、美国、47714
        • MediSphere Medical Research, LLC
    • Iowa
      • West Des Moines、Iowa、美国、50265
        • Integrated Clinical Trial Services, Inc
    • Kansas
      • Overland Park、Kansas、美国、66210
        • International Clinical Research Institute, Inc.
    • Louisiana
      • Bossier City、Louisiana、美国、71111
        • Willis-Kinghton Physician Network / River Cities International Pain Specialist
      • Metairie、Louisiana、美国、70006
        • Clinical Trials Management, LLC
      • New Orleans、Louisiana、美国、70115
        • Best Clinical Trials, LLC
      • Shreveport、Louisiana、美国、71105
        • River Cities Clinical Research Center
    • Massachusetts
      • Watertown、Massachusetts、美国、02472
        • MedVadis Research Corp.
    • Michigan
      • Bay City、Michigan、美国、48706
        • Great Lakes Research Group, Inc.
    • Mississippi
      • Biloxi、Mississippi、美国、39531
        • The Center for Clinical Trials
    • Nevada
      • Las Vegas、Nevada、美国、89119
        • Office of Robert Kaplan, DO
    • New Jersey
      • Berlin、New Jersey、美国、08009
        • Comprehensive Clinical Research
    • New York
      • Great Neck、New York、美国、11023
        • Long Island Gastrointestinal Research Group
      • Williamsville、New York、美国、14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Greensboro、North Carolina、美国、27408
        • Pharmquest, LLC
      • Winston-Salem、North Carolina、美国、27103
        • The Center for Clinical Research
    • North Dakota
      • Fargo、North Dakota、美国、58104
        • Plains Medical Clinic, LLC
    • Ohio
      • Beavercreek、Ohio、美国、45432
        • Clinical Inquest Center, Ltd
      • Cincinnati、Ohio、美国、45242
        • New Horizons Health Research
      • Franklin、Ohio、美国、45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73109
        • Health Research Institute
      • Oklahoma City、Oklahoma、美国、73109
        • Neuropsychiatric Research Center Research
    • Pennsylvania
      • Downingtown、Pennsylvania、美国、19335
        • Brandywine Clinical Research
      • Duncansville、Pennsylvania、美国、16635
        • Altoona Center for Clinical Research
    • South Dakota
      • Rapid City、South Dakota、美国、57702
        • Health Concepts
    • Texas
      • Austin、Texas、美国、78731
        • FutureSearch Clinical Trials
      • Dallas、Texas、美国、75230
        • KRK Medical Research
      • Dallas、Texas、美国、75231
        • Future Search Trials of Dallas, LP
      • Houston、Texas、美国、77074
        • Clinical Trial Network
      • Houston、Texas、美国、77062
        • Advanced Clinical Research of Houston
      • San Antonio、Texas、美国、78229
        • Innovative Clinical Trials
    • Utah
      • Salt Lake City、Utah、美国、84124
        • Highland Clinical Research

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:

  • Diagnosis of moderate to severe low back pain for ≥6 months
  • Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
  • Stable health, as determine by Principal Investigator
  • Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year
  • Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

  • Current cancer related pain or received chemotherapy within 6 months of screening
  • Subjects with history of other chronic painful conditions
  • Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
  • Allergy or contraindications of any opioid or acetaminophen
  • Surgical procedure for relief of pain within 6 months
  • Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
  • QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
  • History of long QT syndrome or a family member with this condition
  • Moderate to severe hepatic impairment
  • Moderate to severe renal impairment
  • Current or past history of alcohol abuse
  • Positive urine toxicology screen for drug of abuse
  • History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：盐酸丁丙诺啡口腔贴膜
每日两次给药
药品：Buprenorphine
Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
其他名称：
  • BEMA 丁丙诺啡
  • 贝尔布卡
  • EN3409
  • 盐酸丁丙诺啡口腔贴膜
安慰剂比较：Placebo Buccal Film
Twice Daily Dosing
药品：安慰剂
每天两次匹配安慰剂颊膜
其他名称：
  • 安慰剂颊膜
  • BEMA安慰剂

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
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
大体时间：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).
Baseline, week 12

次要结果测量

结果测量
措施说明
大体时间
双盲治疗阶段（最多 12 周）治疗失败的参与者百分比
大体时间：治疗失败或双盲治疗阶段结束的基线（最多 12 周）
治疗失败定义为由于缺乏疗效而终止研究或由于双盲治疗阶段的不良事件而终止研究。
治疗失败或双盲治疗阶段结束的基线（最多 12 周）
患者总体印象改变
大体时间：第 12 周
受试者使用患者整体印象变化 (PGIC) 调查问卷评估了他们活动受限的变化，因为他们与他们开始治疗后的疼痛状况有关，该问卷采用 7 分制，范围从 1（没有变化 [或情况变得更糟]）到 7 （好多了，而且相当大的改进使一切变得不同）
第 12 周
Number of Participants With Response to Treatment (Responder) Using NRS Scale
大体时间：Prior to open-label titration to week 12 in double-blind treatment
Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. 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).
Prior to open-label titration to week 12 in double-blind treatment
Number of Subjects With Opioid Rescue Medication Use
大体时间：Week 1 to Week 12
Use of analgesic rescue medication recorded in subject diary
Week 1 to Week 12
Time to Optimal Dose of Open-label Study Medication
大体时间：Up to 8 weeks in open-label titration
Overall time to reach the "optimum" dose of study medication required to progress to double-blind treatment
Up to 8 weeks in open-label titration
Change From Baseline to Week 12 in Roland Morris Disability Questionnaire
大体时间：Baseline, week 12
Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.
Baseline, week 12
Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale
大体时间：Baseline, Week 12
Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).
Baseline, Week 12
Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep
大体时间：Week 12
Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.
Week 12

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。

赞助

BioDelivery Sciences International

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

2012年9月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2012年8月27日

首先提交符合 QC 标准的

2012年8月27日

首次发布 (估计)

2012年8月29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

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EN3409-307

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.

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