Actively Recruiting

Phase 4
All Genders
NCT05799105

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

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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

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with marginal ulceration after gastric bypass seen on upper endoscopy
Not Eligible

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

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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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