NCT01090596已完成不适用
Changes in mRNA Expression Following Exposure to Naproxen
Research Associates of New York, LLP0 个研究点目标入组 48 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Fold Change in Gene Expression
研究概览
简要总结
Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from individuals treated with placebo.
详细描述
We will use microarray technology to quantify the transcriptome-wide changes in gene expression in said-samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult between the ages of 18 and 75 inclusive
- •Written informed consent prior to undergoing any study procedures
- •A physical examination which reveals no clinically significant abnormalities
- •Female subjects of childbearing potential must be taking an acceptable form of contraceptive
排除标准
- •Any mucosal breaks within 2 cm of pyloric channel seen on baseline endoscopy
- •Any GDU or >5 gastroduodenal erosions at baseline endoscopy
- •CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks
- •Previous gastrointestinal ulcer
- •Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments
- •Baseline complaints of abdominal pain, nausea, and/or cramping
- •Any acid blocking medication including antacids, H-2 receptor blocker within the prior 2 weeks, or PPI use within the prior 30 days
- •Corticosteroids use within the prior 60 days
- •Any documented bleeding tendency
- •Has taken warfarin within the prior 60 days
- •Three or greater alcoholic beverages daily
- •History of cerebro-vascular event
研究组 & 干预措施
Naproxen-Treated
Active Comparator
干预措施: Naproxen (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Fold Change in Gene Expression
时间窗: 7 days
次要结局
未报告次要终点
研究者
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