NCT00872534已完成1 期
A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers
PLx Pharma6 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
研究概览
简要总结
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) 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
- Single (Investigator)
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
- •Subject is ≥50 to ≤75 years of age.
- •Subject is healthy.
- •Subject has a BMI between 20 and 32
- •If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.
排除标准
- •Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
- •Subject has an active Helicobacter pylori infection.
- •Subject has a prior GI ulcer, bleeding, obstruction or perforation.
- •Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
- •Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
- •Subject has used an investigational agent within the past 30 days.
- •Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
研究组 & 干预措施
Aspirin
Active Comparator
Immediate release 325mg aspirin
干预措施: acetylsalicylic acid (Drug)
PL-2200
Experimental
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
干预措施: acetylsalicylic acid (Drug)
结局指标
主要结局
Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
时间窗: After 7 days of study medication
Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).
次要结局
未报告次要终点
研究者
研究点 (6)
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