NCT01096966已完成2 期
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Bupivacaine TTS (Bupivacaine Patch) in Patients With Chronic Low Back Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 263
- 主要终点
- Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
研究概览
简要总结
This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic low back pain for more than 3 months
- •If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration
- •Pain intensity score greater than or equal to 5 out of 10 at the first visit
- •Able to apply patches at home
- •Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study
- •Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study
排除标准
- •History of, or ongoing, alcohol or drug abuse
- •Positive drug test for alcohol, illicit drug use or opioids
- •Primary diagnosis of chronic low back pain due to neuropathic pain
- •History of back surgery or plan for back surgery
- •Use of opioids within 2 weeks of the first visit and during the study
- •Previous ineffective use of lidocaine patches
- •Morbid obesity
- •Moderate or severe depression
- •An open skin lesion within the painful area where patches will be applied
- •Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain
- •Pregnant or breastfeeding females
研究组 & 干预措施
Bupivacaine TTS
Experimental
干预措施: Bupivacaine TTS (Bupivacaine Patch) (Drug)
Placebo patch
Placebo Comparator
干预措施: Placebo patch (Drug)
结局指标
主要结局
Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
时间窗: baseline to 12 weeks after baseline
次要结局
- Subjects achieving 20% pain relief at 12 weeks compared to baseline(baseline to 12 weeks after baseline)
- Subjects 'much improved' or 'very much improved' at 12 weeks(12 weeks after baseline)
研究者
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