2.1. Patients
gastrointestinal symptoms, myocardial infarction, GI malignancy, hypersensitivities, lactase deficiency, thrombotic disorder, cerebral infarction, peptic ulcer
GALACTOSE INTOLERANCE, GASTRIC EROSION, PEPTIC ULCER PERFORATION, THROMBOPHLEBITIS, DISEASE, CHRONIC GASTRITIS, GENETIC DISORDERS, ZOLLINGER-ELLISON SYNDROME, HYPERSENSITIVITIES, COAGULATION DISORDER, ACUTE AND CHRONIC GASTRITIS, THROMBOTIC DISORDER, DISEASES, REFLUX ESOPHAGITIS, PEPTIC ULCER
Subjects who participated in the clinical study underwent blood tests, urinalysis, and esophagogastroduodenoscopy (EGD) screening tests. Inclusion criteria were: male and female patients aged ≥ 19 years with acute or chronic gastritis and one or more gastric erosion on baseline EGD and with gastrointestinal symptoms at the time of enrollment or within 7 days. The acute and chronic gastritis were determined based on the investigator judgement, and criteria such as patient symptoms or disease duration were not set. Exclusion criteria were: patients who were unavailable for EGD; patients with a history of peptic ulcer or reflux esophagitis; patients who had undergone gastrointestinal surgery, such as surgery to inhibit gastric acid secretion or esophagogastric surgery (except simple closure of peptic ulcer perforation); patients with a history of GI malignancy or Zollinger-Ellison syndrome; patients with a history of thrombotic disorder (cerebral infarction, myocardial infarction, thrombophlebitis) or coagulation disorder; patients who had used anti-thrombotic agents such as warfarin; patients with abnormal aspartate aminotransferase or alanine aminotransferase (>2 times the upper limit of normal [ULN]); patients with abnormal serum creatinine (>1.5 times ULN); patients who took any of the following drugs within 2 weeks before enrollment (H2RAs, PPIs, antacids, potassium competitive acid blockers, prokinetics, prostaglandin analogs, gastric mucosal protective agents, corticosteroids, nonsteroidal anti-inflammatory drugs, aspirin); known hypersensitivities to the study drug; genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; any other clinical trial medications within 3 months before enrollment; pregnant or lactating patients; fertile women who did not consent to using medically-permitted contraceptive methods (condoms, diaphragms, oral contraceptives, injectable contraceptives, or intrauterine devices), or those with any other conditions or diseases that were regarded unsuitable by the investigator. Subjects who met the inclusion criteria were subsequently randomized to 2 treatment groups. Participants in each group received CKD-495 75 mg or AAF 60 mg (Stillen