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Official title The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
ClinicalTrials.gov ID: NCT05320796
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Schlieren, Schlieren, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Schlieren, Schlieren, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.