NCT01139190已完成2 期
A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage
PLx Pharma2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Degree of GI Injury at Day 15
研究概览
简要总结
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PL3100
Experimental
干预措施: PL3100 (Drug)
Naproxen
Active Comparator
干预措施: Naproxen (Drug)
结局指标
主要结局
Degree of GI Injury at Day 15
时间窗: 15 days
Degree of mucosal injury was assessed by endoscopy, with the following scoring system: Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: \> 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: \> 10 erosions and/or an ulcer
次要结局
未报告次要终点
研究者
研究点 (2)
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