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Should you open that pill? new study tests ulcer healing after bypass surgery

NCT ID NCT05799105

Disease control Sponsor: Stephen Firkins Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether opening a capsule of the acid-blocking drug omeprazole helps heal stomach ulcers faster in people who have had gastric bypass surgery. About 122 participants will be randomly assigned to take the capsule whole or opened. Doctors will check ulcer healing with a camera every three months. The goal is to find the simplest, most effective way to treat these ulcers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omeprazole (Prilosec, Losec)
What this could lead to
If opening the capsule works better, it could give gastric bypass patients a simple way to heal ulcers faster and avoid extra procedures.
What could go wrong
This is a small, early-phase trial with only 122 people. The results may not apply to everyone, and there is no guarantee that opening the capsule will improve healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastrojejunal ulcer peptic ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Marginal ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

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