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OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers

NCT05799105 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-03-19

No results posted yet for this study

Summary

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

  • Marginal Ulcer

Interventions

DRUG

Omeprazole 40 milligrams

Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.

Sponsors & Collaborators

  • Stephen Firkins

    lead OTHER

Principal Investigators

  • Stephen Firkins, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2027-03-23
Completion
2027-03-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05799105 on ClinicalTrials.gov