EUCTR2011-002143-95-NO进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Chronic Low Back Pain
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Between 18 and 70 years of age
- •2) History of CLBP below the 12th thoracic vertebrae and above the crease of the buttocks, = 6 months duration
- •3) Requires thereapeutic doses of at least 1 oral analgesic for CLBP (NSAIDS, COX-2 inhibitors, Tramadol or tapentadol, opioids) during the previous 3 months with a stable dose for at least 4 days per week during the 4 weeks prior to Screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) Has CLBP with any of the following a) pain with distal extremity radiation b) pain with radiation and neurologic findings c) spinal nerve root compression
- •2) Has any of the following spinal cord conditions a) tumor, b) infection of the spinal cord or surrounding structures within the past 5 years, c) spinal stenosis with neurogenic claudication, d) spondylolisthesis with distal radiation and/or neurologic findings, e) seronegative spondylarthropathy
- •3) Has osteoarthritis of the large joints as evidenced by a) history or prior diagnosis of OA in the knee, hip or shoulder, b) clinical findings consistent with ACR Clinical and Radiographic Criteria for OA of the knee, hip or shoulder, or radiographic findings of OA in the knee, hip or shoulder (Kellgren-Lawrence = 2),
- •4) History of osteonecrosis or rapidly progressive osteoarthritis in any joint
研究者
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