The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
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(s) | Obesity, Gastric Reflux, Ulcer, Gastric |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Prof Urs Zingg |
| Locations | Schlieren, Schlieren, Switzerland |
| Start date | 2023-11-01 |
| NCT ID | NCT05320796 |
| Official listing | https://clinicaltrials.gov/study/NCT05320796 |