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NCT05799105 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Marginal Ulcer, sponsored by Stephen Firkins.

Recruiting
Registry status
Phase 4
Development phase
122
Enrollment target
1
Study location

NCT05799105 is a Phase 4 study of Marginal Ulcer that is actively recruiting participants, run by Stephen Firkins. The registered enrollment target is 122 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT05799105, a Phase 4 study of Marginal Ulcer, is actively recruiting participants, sponsored by Stephen Firkins.

RECRUITING
Registry status
Phase 4
Development phase
122 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG Omeprazole 40 milligrams

Study Locations (1)

Ohio

  • Cleveland Clinic Foundation - Cleveland

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2023-03-14
Est. Completion 2027-03-23
Phase Phase 4

Sponsor

Stephen Firkins

2 total trials

What the Registry Record Tells You About NCT05799105

The ClinicalTrials.gov registry entry for NCT05799105 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stephen Firkins, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Marginal Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Omeprazole 40 milligrams is the first listed.

NCT05799105 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT05799105 about?

NCT05799105 is a clinical study titled "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 ta...

What is the current status of trial NCT05799105?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 122 participants. The study started on 2023-03-14. Estimated completion is 2027-03-23.

What conditions does trial NCT05799105 study?

This clinical trial studies the following conditions: Marginal Ulcer.

What interventions are being tested in trial NCT05799105?

The interventions under investigation include: Omeprazole 40 milligrams (DRUG).

Who is sponsoring clinical trial NCT05799105?

This trial is sponsored by Stephen Firkins, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05799105 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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