EUCTR2015-003782-28-DK进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLEDPHASE 2/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OFFASINUMAB IN PATIENTS WITH MODERATE TO SEVERE CHRONIC LOWBACK PAI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •Key Inclusion Criteria:
- •1. Male or female =35 years of age at the screening visit
- •2. Clinical diagnosis of chronic moderate to severe LBP (non-radiculopathic) for =3 months
- •3. History of regular analgesic medication
- •4. History of inadequate pain relief or intolerance to analgesics used for chronic LBP
- •5. Willing to discontinue current pain medication
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •Key Exclusion Criteria:
- •1. History of lumbosacral radiculopathy within the past 2 years
- •2. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
- •3. Recent use of longer acting pain medications
- •4. Evidence of destructive arthropathy
- •5. Other medical conditions that may interfere with participation or accurate assessments during the trial
研究者
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