The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorProf Urs Zingg
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- upper endoscopy
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Prof Urs Zingg
Lead sponsor
Spital Limmattal Schlieren
Sponsor institution
Source ClinicalTrials.gov