Phase IIIb, Randomized, Triple-blinded and Crossover Study to Evaluate the Effect of Magnesium Pantoprazole 20mg Bid Versus Magnesium Pantoprazole 40mg qd on Intragastric Acid Inhibition Assessed by pHmetry, in Healthy Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.
研究概览
简要总结
The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and standard dose of proton pump inhibitors.
详细描述
Eligible healthy volunteers will be randomly assigned for 2 different treatment sequences: A) magnesium pantoprazole 20 mg b.i.d. followed by magnesium pantoprazole 40 mg q.d. or B) magnesium pantoprazole 40 mg q.d. followed by magnesium pantoprazole 20 mg b.i.d.
Treatment sequences will be administrated as follows: 6 days with the first medication, followed by a washout period of 8 days (no medication) and a further period of 6 days with the second medication.
Treatment efficacy will be established by the percentage of time with intragastric pH >4, measured by 24-hour pH-Metry on day 6 of each medication (on-treatment measurement). Basal pH will be measured as reference.
The blinding distribution of treatments will be maintained for the patients, the doctor and the statistician who will analyze the data.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Magnesium Pantoprazole 20mg
干预措施: Magnesium Pantoprazole 20 mg (Drug)
Magnesium Pantoprazole 40mg
干预措施: Magnesium Pantoprazole 40 mg (Drug)
Magnesium Pantoprazole 40mg
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.
时间窗: Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.
Electrode will be placed in the gastric lumen, 10 cm below the lower esophageal sphincter. The percentage of time with pH \>4.0 between both treatments will be compared.
次要结局
- Vital signs, physical exploration and common laboratory tests (if required).(Day 0 (baseline) and day 6 of each treatment period.)