NCT00655291已完成3 期
Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery
Xanodyne Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2008年4月最近更新:
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
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Average pain over a fixed dosing period
研究概览
简要总结
The purpose of this study is to determine if XP20B is an effective treatment for the relief of 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •having undergone bunionectomy surgery
- •having achieved the requisite level of pain
排除标准
- •pregnant or lactating
- •history of substance abuse
- •clinically significant condition or lab abnormality
- •taken any prohibited medications
- •gastrointestinal bleeding or history of
研究组 & 干预措施
A
Placebo Comparator
干预措施: Placebo (Drug)
B
Experimental
干预措施: XP20B (Drug)
结局指标
主要结局
Average pain over a fixed dosing period
时间窗: Multiple-day
次要结局
- multiple pain assessments over a fixed dosing period(Multiple-day)
- Rescue medication use(Multiple-day)
- Safety evaluations(Multiple-day)
研究者
研究点 (2)
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