The Bioavailability and Effect on Pouch pH of Esomeprazole as Tablets or in Solution After Laparoscopic Proximal RYGB for Morbid Obesity - an Investigator Blinded Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- pH
研究概览
简要总结
The objective of this study is to investigate the effect of Esomeprazol administered in tablets (Esomeprazol MUT Sandoz® 40mg) or in solution (Esomeprazol MUT Sandoz® 40mg in 10ml tap water) on acid production in the gastric pouch by measuring the intragastric pH and the serum concentration of esomeprazole.
详细描述
To assess the clinical effect of the esomeprazole absorption after Roux-en-Y gastric bypass, we intend to measure the serum concentration after administration as intact capsules or open in solution and correlate it with the pH in the gastric pouch, measured with the wireless BRAVOTM capsule pH measurement system. The feasibility and safety of the wireless pH monitoring system has been shown before.
The patients who met all the inclusion criteria undergo a routine upper endoscopy one year after RYGB. At the end of the endoscopy, the wireless BRAVO™ - pH monitoring device is placed and the participant is discharged with ongoing pH monitoring. The next day, the participant is randomized to either receive Esomeprazol MUT Sandoz® tablet 40mg or Esomeprazol MUT Sandoz® 40mg in solution. Serum concentration of Esomeprazol is measured at 0, 60 and 120 minutes and the patient is discharged after. After 48 hours of pH monitoring, the patient returns the BRAVO™ - recorder, adverse events are assessed and the study is terminated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proximal Roux-en-Y gastric bypass with linear stapled anastomosis 12 months prior to the study investigation
- •Routine administration of proton pump inhibitors for 6 months postoperatively
- •No intake of proton pump inhibitors at least 4 weeks prior to study investigation
- •No marginal ulcers in upper endoscopy prior to placement of wireless BRAVO™ pH monitoring capsule
- •No symptoms related to gastro-esophageal reflux or marginal ulcers (i.e. epigastric pain, retrosternal burning, regurgitation)
- •Informed consent as documented by signature
排除标准
- •Known intolerance or allergy for Esomeprazol
- •Contraindication for upper endoscopy
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Women who are pregnant or breast feeding Major hepatic dysfunction
研究组 & 干预措施
Solution
Esomeprazol MUT Sandoz® 40mg as a single dose will be dissolved in 10ml tap water to create a solution and then applied per oral
干预措施: upper endoscopy (Diagnostic Test)
Tablet
Esomeprazo MUT Sandozl® 40mg tablet as a single dose will be given orally
干预措施: upper endoscopy (Diagnostic Test)
结局指标
主要结局
pH
时间窗: 48 hours
The primary outcome is the total time, in which the pH in the gastric pouch is \<4 measured with wireless BRAVO™ - pH monitoring.
次要结局
- serum concentration(2 hours after administration)
研究者
Prof Urs Zingg
Prof. Dr.
Spital Limmattal Schlieren