NCT03874247Unknown3 期
A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- SPID-D3
研究概览
简要总结
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, ages over 19 years
- •Patients with post traumatic acute pain within 48 hr(sprain/strain)
- •Patient whose pain scale is over 50 mm(VAS score)
排除标准
- •Patients with chronic pain
- •Presence of a fracture or more than one injury
- •Previous adverse reaction or known allergy to NSAIDs
研究组 & 干预措施
Pelubiprofen
Experimental
干预措施: pelubiprofen 45mg (Drug)
Pelubiprofen placebo
Placebo Comparator
干预措施: pelubiprofen placebo (Drug)
结局指标
主要结局
SPID-D3
时间窗: Day 3
Sum of Pain Intensity Differences(100 mm pain VAS)
次要结局
未报告次要终点
研究者
研究点 (1)
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