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OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers
OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery
Who can join
All ages · All sexes
Full eligibility 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
About the study
The goal of this clinical trial is to identify the most effective way to take acid-blocking medications to treat stomach ulcers in patients who have undergone gastric bypass surgery. The main questions it aims to answer are:
* is taking an acid-blocking medication by opening the capsule and only taking the contents of the capsule (open-capsule) more or less effective than taking the capsule as a whole (intact-capsule) for treating ulcers in patients who have a history of gastric bypass surgery? * does taking the open versus intact medication decrease the number of procedures and complications from untreated ulcers?
Participants with ulcers will be instructed to take acid-blocking medications (called proton-pump inhibitors) either by opening the capsule and taking only the contents or by taking the capsule whole. These medications are the gold standard for treatment of stomach ulcers. Participants will be asked to undergo an upper endoscopy (EGD) every 3 months to monitor the healing of the ulcers.
Researchers will compare how quickly the ulcers heal depending on which way the medications are taken (opened up or as a whole).
What is being tested
- Omeprazole 40 milligrams (drug)
Sponsor: Stephen Firkins · Participants: 122 · Started: Mar 14, 2023
Contact the study team
- Stephen Firkins, MD · Phone: 216-444-8460
Official record on ClinicalTrials.gov — NCT05799105
Locations in the U.S.
| Ohio | Cleveland Clinic Foundation, Cleveland |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.