New hope for steroid users: drug may prevent stomach pain
NCT ID NCT05946135
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether the drug fexuprazan can prevent or control stomach inflammation (gastritis) in people who need to take systemic steroids for at least 4 weeks. 42 adults with respiratory diseases were randomly assigned to take either fexuprazan or the standard drug lansoprazole daily. After 4 weeks, researchers compared changes in gastritis symptoms between the two groups.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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42 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. A person who voluntarily signed a consent form 2. Adult men and women over 20 years of age 3. 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 are already on steroids can also participate (If there is a gastric protective agent in use, patients should agree to replace it with clinical trial drug) 4. Patients who satisfy both of the following in relation to the evaluation index of gastritis symptoms during screening \- Gastritis symptom frequency indicator: 5 points or less \- Gastritis symptom intensity indicator: 5 points or less 5. A person who has at least one of the following risk factors for gastric ulcer during screening ① Long-term use of NSAIDs for longer than 12 weeks (NSAIDs should be maintained continuously during the clinical trial.) ② A person who has a history of peptic ulcer in the past ③ 50 years of age or older ④ In combination with low-dose aspirin (aspirin 325 mg/day or less) (Low-dose aspirin should be maintained continuously during the clinical trial.) 6. 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: 1. 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 2. 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 3. Those who have a history of gastrointestinal malignancies within 5 years of screening (excluding after endoscopic resection of gastric carcinoma or early gastric cancer) 4. Patients with Barrett's esophagus (over 3 cm), gastroesophageal varices, esophageal stenosis, ulcer stenosis, active peptic ulcers, and acute gastrointestinal bleeding 5. Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis 6. Patients with eosinophilic esophagitis (if the esophageal biopsy determines that it is not eosinophilic esophagitis, they can participate) 7. Those who have a history of gastric acid secretion disorders such as Zolinger-Elison syndrome 8. A person who is currently confirmed positive for Helicobacter pyrroly infection 9. Persons taking medications contraindicated to clinical trial drug (e.g., atazanavir, nelfinavir, or rilpivirine-containing agents) 10. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder 11. Patients with severe renal and liver disorders according to the physician's judgment 12. A person who disagrees with the appropriate use of contraception by himself/herself or his/her partner during the clinical trial period 13. Pregnant women or breast feeding women 14. Any person who has any clinical findings that are deemed medically inappropriate for this trial under the judgment of the research manager
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Severance Hospital
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Gastritis drug showdown: which version works better?