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OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers
NCT05799105 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2023-03-14 |
| Est. Completion | 2027-03-23 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05799105
The ClinicalTrials.gov registry entry for NCT05799105 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05799105 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05799105?
The interventions under investigation include: Omeprazole 40 milligrams (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05799105?
This trial is sponsored by Stephen Firkins, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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