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OpenTrials
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NCT Number: NCT05799105

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

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).

Recruiting

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Key information

Conditions

Marginal Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Stephen Firkins, MD

CONTACT

[email protected]

216-444-8460

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole 40 milligrams

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Firkins, MD

CONTACT

[email protected]

216-444-8460

Sponsors and collaborators

Lead sponsor

Stephen Firkins

Other

Registry information

Official study title

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

Acronym: OPEN-IT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 5, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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