Clinical trial
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Recruiting now · Phase 4 · 1 countries · Registry ID NCT05320796
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
upper endoscopy
A 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.
Primary outcomes
The primary outcome is the total time, in which the pH in the gastric pouch is \<4 measured with wireless BRAVO™ - pH monitoring.