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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
upper endoscopy
Diagnostic testA 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SolutionExperimental treatment 1 intervention
Group B: TabletActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
pH
The primary outcome is the total time, in which the pH in the gastric pouch is \<4 measured with wireless BRAVO™ - pH monitoring.
Time frame
48 hoursSecondary outcomes
1
serum concentration
The main secondary outcome is the serum concentration of Esomeprazol in nanogramm per mililiter in the blood serum at 0, 60 and 120 minutes after drug administration either as tablet or in solution.
Time frame
2 hours after administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof Urs Zingg
Lead sponsor
Spital Limmattal Schlieren
Sponsor institution
Source ClinicalTrials.gov