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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: Recruiting Phase 4 study of Marginal Ulcer, sponsored by Stephen Firkins.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Rate of ulcer healing in each treatment arm, defined as resolution of previously-seen ulcer on upper endoscopy
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 |
What NCT05799105 shows while recruiting
NCT05799105 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Marginal Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05799105's enrollment target sits among peer trials
122 665th of 2000 higher than 1,333 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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