Efficacy of Fexuprazan for Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids

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 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)
• 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
• 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.)

• 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

• 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
• Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility disorder, and pancreatitis
• Patients with eosinophilic esophagitis (if the esophageal biopsy determines that it is not eosinophilic esophagitis, they can participate)
• Those who have a history of gastric acid secretion disorders such as Zolinger-Elison syndrome
• A person who is currently confirmed positive for Helicobacter pyrroly infection
• Persons taking medications contraindicated to clinical trial drug (e.g., atazanavir, nelfinavir, or rilpivirine-containing agents)
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
• Patients with severe renal and liver disorders according to the physician's judgment
• A person who disagrees with the appropriate use of contraception by himself/herself or his/her partner during the clinical trial period
• Pregnant women or breast feeding women
• Any person who has any clinical findings that are deemed medically inappropriate for this trial under the judgment of the research manager