NCT00366262已完成1 期
A Randomized, Double-Blind, Parallel Group Study To Compare The 7-Day Gastrointestinal Safety of 2 Doses of PLA-695 To That Of Placebo And Naproxen
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
研究概览
简要总结
The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women of nonchildbearing potential, aged 18 to 60 years.
排除标准
- •Abnormal baseline endoscopy.
- •Positive Helicobacter pylori serology.
结局指标
主要结局
The rate of erosions and ulcers present after 7 days of treatment for PLA-65 will be compared to placebo and naproxen.
次要结局
未报告次要终点
研究者
研究点 (1)
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