Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment W… (NCT05946135) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids
South Korea42 participantsStarted 2023-11-07
Plain-language summary
* This clinical trial is conducted as a double-blind, randomized, and active drug control clinical trial. If the screening results determine that the selection/exclusion criteria are met, the clinical trial drugs are randomly assigned at a 1:1 ratio of the Pexuprazan 40 mg and the Lansoprazole 15 mg dose group and taken for 4 weeks.
* Gastritis symptoms are evaluated four weeks after baseline (Visit1) and clinical drug administration (Visit2), and if it is determined that gastritis is necessary according to the medical team's judgment due to gastrointestinal symptoms during the study participation period, endoscopy is performed to check whether gastritis occurs.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A person who voluntarily signed a consent form
. Adult men and women over 20 years of age
. Patients who require systemic steroid treatment of at least 4 weeks of moderate dose (20 mg/day or more based on prednisolone) due to respiratory diseases during screening
. Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening
. A person who has at least one of the following risk factors for gastric ulcer during screening
. A person who understand and follow the guidance of the research manager according to the research plan, and who can participate whole period of clinical trial
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in baseline gastritis symptoms based on gastritis symptom index at 4 weeks
. A person who has a hypersensitivity reaction to the components of this clinical trial drug or benzimidazole-based drug or has a history of clinically significant hypersensitivity reaction
. A person who has undergone surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion inhibition surgery, and gastric mucosal resection
. Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer)
. Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding