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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Spital Limmattal
RECRUITING
Schlieren
Contact Information
Primary
Urs Zingg, Prof.
Urs.Zingg@spital-limmattal.ch
+41 44 733 21 26
Backup
Patrizia Heeb
patrizia.heeb@spital-limmattal.ch
+41 44 736 85 76
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
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
Active_comparator: Tablet
Esomeprazo MUT Sandozl® 40mg tablet as a single dose will be given orally
Related Therapeutic Areas
Sponsors
Leads: Prof Urs Zingg

This content was sourced from clinicaltrials.gov