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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320796
• Other study ID #: LS-202112
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Spital Limmattal Schlieren
• Contact: Urs Zingg, Prof.
• Phone: +41 44 733 21 26
• Email: Urs.Zingg[@]spital-limmattal.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To assess the clinical effect of the esomeprazole absorption after Roux-en-Y gastric bypass, we intend to measure the serum concentration after administration as intact capsules or open in solution and correlate it with the pH in the gastric pouch, measured with the wireless BRAVOTM capsule pH measurement system. The feasibility and safety of the wireless pH monitoring system has been shown before. The patients who met all the inclusion criteria undergo a routine upper endoscopy one year after RYGB. At the end of the endoscopy, the 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Reflux
• Obesity
• Stomach Ulcer
• Ulcer, Gastric

Intervention

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

Country	Name	City	State
Switzerland	Spital Limmattal	Schlieren

Sponsors (1)

Lead Sponsor	Collaborator
Prof Urs Zingg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH	The primary outcome is the total time, in which the pH in the gastric pouch is <4 measured with wireless BRAVO™ - pH monitoring.	48 hours
Secondary	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.	2 hours after administration