NCT01053702撤回2 期
Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in procedural pain intensity
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury
- •Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days
排除标准
- •Patients with burns caused by chemical exposure or electricity
- •Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection
- •Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries
- •Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments.
- •Women who are pregnant or nursing
研究组 & 干预措施
Dose 1
Experimental
R475
干预措施: R475 (Drug)
Dose 2
Experimental
R475
干预措施: R475 (Drug)
Dose 3
Placebo Comparator
Placebo to match R475 dose
干预措施: Placebo (Drug)
结局指标
主要结局
Change in procedural pain intensity
次要结局
- Cumulative analgesic usage
- Weekly Patient-rated Global Impression of Change
- Additional quality of life assessments
研究者
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