NCT02031211撤回不适用
Etanercept for the Treatment of Chronic Regional Pain Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.
- •Patients must meet CRPS Type I diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb ≥1.0°C.
- •Duration of symptoms less than 4 months.
排除标准
- •Active malignancy or history of malignancy.
- •Active infection.
- •History of Tuberculosis (TB) or TB exposure.
- •Concomitant disease causing immunocompromise.
- •Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.
- •Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.
- •Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age.
- •Evidence of or history of demyelinating disease.
研究组 & 干预措施
Placebo
Placebo Comparator
0.4 ml/kg of normal saline will be administered subcutaneously.
干预措施: Placebo (Drug)
Etanercept
Experimental
Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.
干预措施: Etanercept (Drug)
结局指标
主要结局
Visual Analog Scale
时间窗: 8 weeks
intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups.
次要结局
- Adolescent Pediatric Pain Tool(At end of each week of treatment)
- Skin Temperature and Volume of Affected Limb(At beginning and end of study)
- Hospital Anxiety and Depression Scale(Beginning and end of study)
- Sleep Disturbance Scale for Children(Beginning and end of the study)
- Sleep pattern and quality(Daily)
研究者
Srinivas Naidu
Clinical Assistant Professor
Stanford University
研究点 (1)
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