NCT01675167已完成3 期
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
BioDelivery Sciences International66 个研究点 分布在 1 个国家目标入组 815 人开始时间: 2012年9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
- 已完成
- 发起方
- 入组人数
- 815
- 试验地点
- 66
- 主要终点
- Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •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
排除标准
- •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
研究组 & 干预措施
Placebo Buccal Film
Placebo Comparator
Twice Daily Dosing
干预措施: Placebo (Drug)
Buprenorphine HCl Buccal Film
Experimental
Twice Daily Dosing
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Average Daily Pain Intensity Scores
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
- Number of Participants With Response to Treatment (Responder) Using NRS Scale(Prior to open-label titration to week 12 in double-blind treatment)
- Number of Subjects With Opioid Rescue Medication Use(Week 1 to Week 12)
- Time to Optimal Dose of Open-label Study Medication(Up to 8 weeks in open-label titration)
- 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))
- Patient Global Impression of Change(Week 12)
- Change From Baseline to Week 12 in Roland Morris Disability Questionnaire(Baseline, week 12)
- Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale(Baseline, Week 12)
- Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep(Week 12)
研究者
研究点 (66)
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