Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 63
- 主要终点
- Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7
研究概览
简要总结
This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age.
- •Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor.
- •Participants must have normal or clinically acceptable physical exam and ECG.
- •Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation.
- •Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed.
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.
- •Positive H. pylori breath test at screening.
- •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 significant mental illness, such as schizophrenia or bipolar disorder
- •History (in the past year) suggestive of alcohol or drug abuse or dependence, or excessive alcohol use (>2 units per day on average; for example >2 bottles of beer, >2 glasses of wine, >2 ounces of liquor/spirits), or excessive alcohol use during the study
- •Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
- •Currently using or use of any prescription or over the counter (OTC) medications that affect gastrointestinal function, including first generation antihistamines (e.g. diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment administration.
- •Currently using, or use within 14 days of first treatment administration, or having a history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists, or OTC or Rx use of proton pump inhibitors.
- •Positive urine drug/alcohol test at Screening.
研究组 & 干预措施
Zegerid
Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication.
干预措施: Zegerid (Drug)
Prevacid®
Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication.
干预措施: Prevacid® (Drug)
结局指标
主要结局
Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7
时间窗: Treatment dose to 4-hr post-dose on Day 7
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.
次要结局
- Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1(Treatment dose to 24-hr post-dose on Day 1)
- Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1(Treatment dose to 24-hr post-dose on Day 1)
- Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1(Treatment dose to 4-hours post-dose on Day 1)
- Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing(Treatment dose to event on Day 1 and Day 7)
- The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7(Treatment dose to 4-hr post-dose on Day 1 and Day 7)
- Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7(Treatment dose to 24-hours post-dose on Day 7)
- Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7(Treatment dose to 24-hour post-dose on Day 7)
- Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period(Treatment dose to 4-hr post-dose on Day 1 and Day 7)
- Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7(Treatment dose to 4 hours Post-dose on Day 7)
- Median 24-hr Intragastric pH on Day 7(Treatment dose to 24-hour post-dose on Day 7)
- Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7(Treatment dose to 24-hour post-dose on Day 7)
- Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1(Treatment dose to 4-hr post-dose on Day 1)
- Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7(Treatment dose to 24-hour post-dose on Day 7)
- Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7(Treatment dose to 24-hour post-dose on Day 7)
- Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1(Treatment dose to 24-hour post-dose on Day 1)
- Time to Onset of Inhibition of Acid Secretion on Day 1(Treatment dose to onset of event on Day 1)
- Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7(Treatment dose to 2-hours post-dose on Day 7)