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

NCT05320796 | Recruiting Phase 4 DMC

• 1 other identifier: LS-202112
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Gastric Reflux; Ulcer, Gastric

Outcome Measures

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.

  48 hours

Secondary Outcomes (1)

• serum concentration

  2 hours after administration

Study Arms (2)

Solution

EXPERIMENTAL

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

Tablet

ACTIVE COMPARATOR

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

Diagnostic Test: upper endoscopy

Interventions

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.

Also known as: blood sample

Solution; Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof Urs Zingg: lead

Study Sites (1)

Spital Limmattal

Schlieren, 8952, Switzerland

RECRUITING

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux; Stomach Ulcer

Interventions

Gastroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Officials

• Urs Zingg, Prof.

  Limmattal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urs Zingg, Prof.

CONTACT

+41 44 733 21 26; Urs.Zingg@spital-limmattal.ch

Patrizia Heeb

CONTACT

+41 44 736 85 76; patrizia.heeb@spital-limmattal.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

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

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: April 11, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)