NCT00410592已完成4 期
A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.
研究概览
简要总结
This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Males and females ages 18-69 who are of Hispanic origin
- •Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months
排除标准
- •Female patients who are pregnant or breastfeeding
- •Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix
- •Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery
结局指标
主要结局
To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD.
次要结局
- Compare nocturnal intragastric pH in Hispanic patients with GERD
- Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
- Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
研究者
研究点 (8)
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