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RECRUITING
NCT05320796
PHASE4

The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass

Sponsor: Prof Urs Zingg

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-11-01

Completion Date

2027-12-31

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

Locations (1)

Spital Limmattal

Schlieren, Switzerland