| Eligibility |
Inclusion Criteria:
- Subjects must meet all of the following inclusion criteria to be eligible for this
study:
1. Male or female subjects aged 18-75 years (inclusive);
2. Subjects with a confirmed diagnosis of reflux esophagitis (Grade A-D according to
LA classification) by esophagogastroduodenoscopy (EGD) at our site within 7 days
prior to Visit 2 (date of randomization).
3. Able to understand the information provided and to comply with protocol
requirements;
4. Voluntarily agreed to participate in this clinical study and signed the informed
consent form (ICF).
Exclusion Criteria:
- 1)Subjects who were allergic to the investigational drug and any of its components or
esomeprazole magnesium enteric-coated tablets, other benzimidazole compounds and their
components; 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, active
upper/lower gastrointestinal bleeding, or malignancies confirmed by EGD; 4)Subjects
with Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome, or inflammatory
bowel disease; 5)Subjects with concomitant diseases that may affect esophageal
motility (e.g., dermatosclerosis, viral infection or fungal infection, etc.), or a
history of esophageal radiotherapy or esophageal cryotherapy; 6)Subjects who had
undergone surgery to reduce gastric acid secretion, or any surgery that affected the
structure or function of the esophagus, stomach, or duodenum (excluding benign tumor
excision, endoscopic resection of benign polyps, and simple suture procedures such as
gastric perforation); 7)Subjects with warning symptoms (e.g., odynophagia, severe
dysphagia, bleeding, weight loss, anemia, or hematochezia) of gastrointestinal
malignancies (excluding those who did not have any endoscopically confirmed anatomical
abnormalities of the esophagus or stomach); 8)Subjects with a medical history of
serious hepatic, renal, neurological, respiratory, endocrine, hematological,
cardiovascular, or genitourinary diseases; 9)Subjects with a history of malignancies
within 5 years prior to screening (excluding those who had recovered from
non-digestive malignancies for 5 years and have not relapsed); 10)Subjects with a
medical history of psychiatric disorders (excluding those with psychiatric disorders
who were currently stable as judged by the investigator and were not receive
treatment), or drug or alcohol abuse within 12 months prior to screening; 11)Subjects
who 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 at
screening; 13)Subjects who used therapeutic doses of drugs for gastroesophageal reflux
disease within 7 days prior to randomization, such as proton pump inhibitors,
potassium competitive acid blockers, histamine H2 receptor antagonists, mucosal
protective drugs, drugs promoting gastrointestinal motility, and traditional Chinese
medicinal products for gastroesophageal reflux disease; 14)Subjects with alanine
aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin = 2 ×
upper limit of normal (ULN); creatinine (Scr) = 1.5 × ULN at screening; 15)Subjects
who were positive for human immunodeficiency virus (HIV) or hepatitis B surface
antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening; 16)Pregnant or
lactating women; subjects of childbearing potential who were unable or unwilling to
use adequate contraception from the time of signing the ICF until 30 days after the
last dose or their partners were unwilling to use contraception; 17)Subjects who have
participated 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.
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