Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 30
- 主要终点
- Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment
研究概览
简要总结
This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:
- provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments;
- compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
- evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
详细描述
Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week washout period between treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.
- •Physical examination findings within normal limits for age.
排除标准
- •History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
- •History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
- •Participation in any study of an investigational treatment in the 30 Days before Screening or participation in another study at any time during the period of this study
- •Any significant medical illness that would contraindicate participation in the study
- •Gastrointestinal disorder or surgery leading to impaired drug absorption
- •Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
- •Current use of any prescription or OTC medications that affect gastrointestinal function.
- •Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.
研究组 & 干预措施
Placebo
Inert substance
干预措施: Placebo (Other)
Zegerid OTC Capsules
20 mg omeprazole and 1100 mg sodium bicarbonate
干预措施: Zegerid (Drug)
Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
20.6 mg omeprazole-magnesium complex.
干预措施: Prilosec OTC™ Tablets (Drug)
结局指标
主要结局
Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment
时间窗: 4 hours after dose on Day 4
Early effectiveness of treatment is evaluated as the percent time with intragastric pH\>4 during the first 4 hours following administration of respective treatments
次要结局
未报告次要终点