A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- pH over 24hours
研究概览
简要总结
Current treatment for gastroesophageal reflux disease (GERD) confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric-acid suppression. Clinical data on AH234844 demonstrates a rapid onset of action, high potency, and prolonged duration of effect. The present study endeavors, in part, to compare lavoltidine to two GERD drugs, NEXIUM and ranitidine.
详细描述
A three-part study in healthy male volunteers to determine the most effective of four different lavoltidine doses on gastric pH and to compare the most effective dose with NEXIUM (esomeprazole) 40mg for the inhibition of gastric-acid secretion and with ranitidine (300mg/day) for the amount of pharmacodynamic tolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject must have a Body Mass Index (BMI) from 19-30 kg/m2
- •Subject does not present with abnormal clinical lab findings
- •Subject is able to tolerate a nasogastric pH electrode.
排除标准
- •Subject is Helicobacter-positive on a C13 urea breath test
- •Subject has a baseline median 24-hour gastric pH>3
- •For Part B of the study, subjects are CYP 2C19 poor metabolizers.
结局指标
主要结局
pH over 24hours
时间窗: over 24hours
次要结局
- %24 hours pH>4 Median gastric pH Adverse events(over 24 hours)