NCT01646814已完成2 期
A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
PLx Pharma0 个研究点目标入组 247 人开始时间: 2012年9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
- 247
- 主要终点
- Incidence of Gastroduodenal Ulcers
研究概览
简要总结
This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.
详细描述
Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.
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 (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
- •Healthy volunteers, ≥50 and ≤75 years of age.
- •No endoscopically observed baseline gastrointestinal lesions.
排除标准
- •Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.
- •Significant history of substance abuse or uncontrolled acute or chronic medical illness.
- •Active H. pylori infection.
- •Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.
- •Hypersensitivity to aspirin or other NSAIDs.
研究组 & 干预措施
PL2200
Experimental
Investigational product, PL2200
干预措施: PL2200 (Drug)
Aspirin tablets
Active Comparator
Active comparator, 325 mg aspirin tablets
干预措施: Aspirin tablets (Drug)
结局指标
主要结局
Incidence of Gastroduodenal Ulcers
时间窗: 42 Days
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
次要结局
- Number of Subjects With Erosion and Ulcers(42 days)
研究者
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