OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers (OPEN-IT)

March 17, 2026 updated by: Stephen Firkins

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Marginal ulcers (ulcers formed at the surgery site between the stomach and the intestines) are a common complication of bariatric surgery, ranging in frequency from 0.6-25% of patients. Furthermore, roughly 17% of patients with marginal ulcers require repeat procedures or surgery for severe complications such as bleeding, perforation, stricture, and fistulas.

Proton pump inhibitors (PPIs), which act by block acid secretion from the stomach, are the gold standard for treatment of ulcers. There is limited data showing that opening the PPI capsule and taking only the contents greatly improves healing of marginal ulcers after gastric bypass surgery. This is likely due to the much smaller stomach, faster passage through the stomach and decreased ability of the intact PPI medication to be broken down and absorbed.

This would be the first clinical trial to confirm whether this is true, which would support all patients who get ulcers after gastric bypass surgery to be treated with open-capsule PPI medications.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-capsule
Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an open-capsule until confirmed ulcer healing.
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.
Other Names:
  • Prilosec
  • Losec
Active Comparator: Intact-capsule
Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an intact-capsule until confirmed ulcer healing or potential cross-over.
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.
Other Names:
  • Prilosec
  • Losec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer healing
Time Frame: On average, 3 months to 12 months
Rate of ulcer healing in each treatment arm, defined as resolution of previously-seen ulcer on upper endoscopy
On average, 3 months to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulcer healing time
Time Frame: On average, 3 months to 12 months
Time to ulcer healing, defined as (date of ulcer healing) - (date of ulcer diagnosis)
On average, 3 months to 12 months
pH of gastric pouch
Time Frame: Upon initial enrollment endoscopy
pH of the gastric pouch fluid will be obtained during initial endoscopy and tested with litmus paper. pH data will be compared between the two treatment arms.
Upon initial enrollment endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephen Firkins

Investigators

  • Principal Investigator: Stephen Firkins, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

March 23, 2027

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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