Comparing two ways of taking acid-blocking medications for stomach ulcers after gastric bypass surgery
Official title: OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery
Run by The Cleveland Clinic · NCT05799105 · Data updated 2026-11-12
This study is testing whether taking acid-blocking medication for stomach ulcers in an open capsule form works better than taking it in a whole capsule for people who have had gastric bypass surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | March 14, 2023 |
| Main results expected | March 23, 2027 |
| Study ends | March 23, 2027 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT05799105 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with marginal ulcers following gastric bypass surgery.
✕Probably not a fit
Patients who are currently using open-capsule PPIs or refuse to start PPI medication will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine the effectiveness of taking proton pump inhibitors (PPIs) in two different forms: as an open capsule versus an intact capsule for treating marginal ulcers in patients who have undergone gastric bypass surgery. Participants diagnosed with marginal ulcers will be instructed to take either the contents of the capsule or the whole capsule, with their healing monitored through regular upper endoscopies. The study seeks to assess whether the open-capsule method leads to better healing outcomes and fewer complications compared to the traditional method. This is the first trial of its kind to explore this approach in this patient population.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with marginal ulcers, potentially reducing complications and the need for additional procedures.
How similar studies have gone: This approach is novel and has not been previously tested in clinical trials for this specific patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy Exclusion Criteria: * Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer
Where it's running
-
Cleveland Clinic Foundation
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Stephen Firkins, MD — The Cleveland Clinic
- Study coordinator: Stephen Firkins, MD
- Email: bariatricendoscopy@ccf.org
- Phone: 216-444-8460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.