NCT00808769已完成4 期
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Procter and Gamble1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Mean Percent Time Gastric pH > 4.0 on Day 1
研究概览
简要总结
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal subjects who are 18-65 years of age;
- •Non-childbearing potential females or those using birth control
排除标准
- •History of significant GI disease
- •Any significant medical illness
- •History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
- •Currently using GI medications
- •GI disorder or surgery leading to impaired drug absorption
研究组 & 干预措施
1
Active Comparator
Zegerid®
干预措施: Zegerid® (Drug)
2
Experimental
Prilosec OTC®
干预措施: Prilosec OTC® (Drug)
结局指标
主要结局
The Mean Percent Time Gastric pH > 4.0 on Day 1
时间窗: continuously over a 24 hour period
In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.
次要结局
未报告次要终点
研究者
研究点 (1)
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