NCT05320796 The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
| NCT ID | NCT05320796 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Prof Urs Zingg |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2023-11-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Urs Zingg, Prof.
PRINCIPAL INVESTIGATOR
Limmattal Hospital
Frequently Asked Questions
Who can join the NCT05320796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05320796 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05320796 currently recruiting?
Yes, NCT05320796 is actively recruiting participants. Contact the research team at Urs.Zingg@spital-limmattal.ch for enrollment information.
Where is the NCT05320796 trial being conducted?
This trial is being conducted at Schlieren, Switzerland.
Who is sponsoring the NCT05320796 clinical trial?
NCT05320796 is sponsored by Prof Urs Zingg. The principal investigator is Urs Zingg, Prof. at Limmattal Hospital. The trial plans to enroll 50 participants.
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