Status:
RECRUITING
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Lead Sponsor:
Prof Urs Zingg
Conditions:
Obesity
Gastric Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 p...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05320796
Start Date
November 1 2023
End Date
December 31 2027
Last Update
May 15 2025
Active Locations (1)
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1
Spital Limmattal
Schlieren, Switzerland, 8952