NCT01743625已完成3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Evaluation of the Safety and Analgesic Efficacy of COV155 Tablets in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 406
- 试验地点
- 5
- 主要终点
- SPID48 (Summed pain intensity difference)
研究概览
简要总结
The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
COV155
Experimental
COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.
干预措施: COV155 (Drug)
Placebo
Placebo Comparator
Matching tablet to COV155 without containing active ingredients, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.
干预措施: placebo (Drug)
结局指标
主要结局
SPID48 (Summed pain intensity difference)
时间窗: 48 hours
48 hour Summed pain intensity difference
次要结局
- Analgesic effects of COV155 versus placebo(48 hours)
- Safety and tolerability of COV155(48 hours)
- Onset of analgesia of COV155 versus placebo(48 hours)
研究者
研究点 (5)
Loading locations...
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