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

Sponsor

Prof Urs Zingg (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05320796

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Gastric Reflux Ulcer, Gastric	Diagnostic Test: upper endoscopy	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Esomeprazol administered in tablets (Esomeprazol MUT Sandoz® 40mg) ¨ or in solution (Esomeprazol MUT Sandoz® 40mg in 10ml tap water)Esomeprazol administered in tablets (Esomeprazol MUT Sandoz® 40mg) ¨ or in solution (Esomeprazol MUT Sandoz® 40mg in 10ml tap water)

Masking:

Single (Investigator)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solution Esomeprazol MUT Sandoz® 40mg as a single dose will be dissolved in 10ml tap water to create a solution and then applied per oral	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. Other Names: blood sample
Active Comparator: Tablet Esomeprazo MUT Sandozl® 40mg tablet as a single dose will be given orally	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. Other Names: blood sample

Arm

Intervention/Treatment

Experimental: Solution

Esomeprazol MUT Sandoz® 40mg as a single dose will be dissolved in 10ml tap water to create a solution and then applied per oral

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.

Other Names:

blood sample

Active Comparator: Tablet

Esomeprazo MUT Sandozl® 40mg tablet as a single dose will be given orally

Diagnostic Test: upper endoscopy

Other Names:

blood sample

Outcome Measures

Primary Outcome Measures

pH [48 hours]
The primary outcome is the total time, in which the pH in the gastric pouch is <4 measured with wireless BRAVO™ - pH monitoring.

Secondary Outcome Measures

serum concentration [2 hours after administration]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Prof Urs Zingg

Investigators

Principal Investigator: Urs Zingg, Prof., Limmattal Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof Urs Zingg, Prof. Dr., Spital Limmattal Schlieren

ClinicalTrials.gov Identifier:

NCT05320796

Other Study ID Numbers:

LS-202112

First Posted:

Apr 11, 2022

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stomach Ulcer

Obesity

Study Results

No Results Posted as of Apr 11, 2022