Actively Recruiting
OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers
Led by Stephen Firkins · Updated on 2026-03-19
122
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with marginal ulceration after gastric bypass seen on upper endoscopy
You will not qualify if you...
- Refusal to start PPI medication
- Current use of open-capsule PPI medication at the time of marginal ulcer diagnosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Stephen Firkins, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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