The Efficacy and Safety of DWP14012 in Chinese Patients With Reflux Esophagitis

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible for thisstudy:

1. Male or female subjects aged 18-75 years (inclusive);
2. Subjects with a confirmed diagnosis of reflux esophagitis (Grade A-D according toLA classification) by esophagogastroduodenoscopy (EGD) at our site within 7 daysprior to Visit 2 (date of randomization).
3. Able to understand the information provided and to comply with protocolrequirements;
4. Voluntarily agreed to participate in this clinical study and signed the informedconsent form (ICF).

Exclusion Criteria:

• 1）Subjects who were allergic to the investigational drug and any of its components oresomeprazole magnesium enteric-coated tablets, other benzimidazole compounds and theircomponents; 2）Subjects who were unable to undergo esophagogastroduodenoscopy (EGD); 3）Subjects with eosinophilic esophagitis, Barrett's esophagus (≥ 3 cm),gastroesophageal varices, stricture of oesophagus, active peptic ulcer, activeupper/lower gastrointestinal bleeding, or malignancies confirmed by EGD; 4）Subjectswith Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome, or inflammatorybowel disease; 5）Subjects with concomitant diseases that may affect esophagealmotility (e.g., dermatosclerosis, viral infection or fungal infection, etc.), or ahistory of esophageal radiotherapy or esophageal cryotherapy; 6）Subjects who hadundergone surgery to reduce gastric acid secretion, or any surgery that affected thestructure or function of the esophagus, stomach, or duodenum (excluding benign tumorexcision, endoscopic resection of benign polyps, and simple suture procedures such asgastric perforation); 7）Subjects with warning symptoms (e.g., odynophagia, severedysphagia, bleeding, weight loss, anemia, or hematochezia) of gastrointestinalmalignancies (excluding those who did not have any endoscopically confirmed anatomicalabnormalities of the esophagus or stomach); 8）Subjects with a medical history ofserious hepatic, renal, neurological, respiratory, endocrine, hematological,cardiovascular, or genitourinary diseases; 9）Subjects with a history of malignancieswithin 5 years prior to screening (excluding those who had recovered fromnon-digestive malignancies for 5 years and have not relapsed); 10）Subjects with amedical history of psychiatric disorders (excluding those with psychiatric disorderswho were currently stable as judged by the investigator and were not receivetreatment), or drug or alcohol abuse within 12 months prior to screening; 11）Subjectswho required continuous treatment with nonsteroidal anti-inflammatory drugs (e.g.,aspirin), systemic glucocorticoids, and antithrombotic drugs during the study (excluding those who used low-dose aspirin [≤ 100 mg/day] prophylactically); 12）Subjects who were taking anti-retroviral drugs such as atazanavir and nelfinavir atscreening; 13）Subjects who used therapeutic doses of drugs for gastroesophageal refluxdisease within 7 days prior to randomization, such as proton pump inhibitors,potassium competitive acid blockers, histamine H2 receptor antagonists, mucosalprotective drugs, drugs promoting gastrointestinal motility, and traditional Chinesemedicinal products for gastroesophageal reflux disease; 14）Subjects with alanineaminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ≥ 2 ×upper limit of normal (ULN); creatinine (Scr) ≥ 1.5 × ULN at screening; 15）Subjectswho were positive for human immunodeficiency virus (HIV) or hepatitis B surfaceantigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening; 16）Pregnant orlactating women; subjects of childbearing potential who were unable or unwilling touse adequate contraception from the time of signing the ICF until 30 days after thelast dose or their partners were unwilling to use contraception; 17）Subjects who haveparticipated and received treatment in clinical studies of other drugs, devices, etc.within 3 months prior to screening; 18）Subjects who were ineligible (for any reason)to participate in the study as judged by the investigator.