Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT05320796

Recruiting nowPhase 4Interventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Gastric Reflux, Ulcer, Gastric

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

upper endoscopy

Diagnostic Test

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

pH48 hours

The primary outcome is the total time, in which the pH in the gastric pouch is \<4 measured with wireless BRAVO™ - pH monitoring.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Spital Limmattal🇨🇭 Schlieren, Schlieren, Switzerland
Patrizia HeebContact