NCT01043263已完成2 期
A Phase IIB, Randomized, Double-blind, Two-arm, Multi-center, Placebo-controlled, Study to Assess the Efficacy and Safety of EN3324 (Axomadol) in Subjects With Moderate to Severe 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
- 入组人数
- 236
- 试验地点
- 59
- 主要终点
- To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain
详细描述
A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe 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, 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
- •18 years of age or older
- •Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year.
- •Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent
- •Have a history of moderate to severe CLBP
排除标准
- •Have evidence of or a history of alcohol and/or drug abuse
- •Have pain secondary to a confirmed or suspected neoplasm
- •Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study
- •Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)
研究组 & 干预措施
EN3324 (axomadol)
Experimental
干预措施: EN3324 (axomadol) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
时间窗: Change from baseline [Day 0] to final visit [Day 112]
次要结局
- To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.(Change from baseline [Day 0] to final visit [Day 112])
- To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.(Change from baseline [Day 0] to final visit [Day 112])
研究者
研究点 (59)
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