A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

Exclusion Criteria

• •1. Researchers believe that patients with uncontrolled primary diseases are not suitable for clinical trials, particularly those with a history of severe conditions affecting the cardiovascular, nervous, respiratory, hepatic, renal, or other systems.
• •2. Patients with concomitant diseases that may affect the esophagus or esophageal motility and, could potentially influence the efficacy evaluation.
• •3. Patients with a history of prior surgical procedures that could potentially impact esophageal function, or surgeries.
• •4. Patients confirmed to have active peptic ulcers or active upper/lower gastrointestinal bleeding within the last 30 days via esophagogastroduodenoscopy (EGD).
• •5. Patients with a history of Zollinger-Ellison syndrome, achalasia of the cardia, secondary esophageal motility disorders, irritable bowel syndrome, inflammatory bowel disease, or other gastrointestinal functional disorders.
• •6. Patients with a history of malignant tumor or having received treatment for malignant tumor within 5 years prior to randomization.
• •7. Patients with a history of mental illness or a history of drug or alcohol abuse within 12 months prior to screening.
• •8. Patients who tested positive for HIV, HBsAg, and/or HCV antibodies during screening.
• •9. Patients with malignant tumors or a predisposition to malignancy in the stomach or esophagus.
• •10. Patients with abnormal liver function: AST and/or ALT levels ≥2.0×ULN, and/or total bilirubin (TBIL) levels ≥1.5×ULN.
• •11. Patients with abnormal renal function: Serum creatinine levels ≥1.5×ULN, blood urea or blood urea nitrogen levels ≥1.5×ULN.
• •12. Patients with clinically significant ECG abnormalities, including QTc interval prolongation (QTcF ≥450 ms for men and QTcF ≥470 ms for women).
• •13. Patients with poorly controlled diabetes or hypertension.
• •14. Patients who were unable to undergo esophagogastroduodenoscopy (EGD).
• •15. Patients with a known allergy to the components or ingredients of Anaprazole or Rabeprazole.
• •16. Patients who had used proton pump inhibitors at therapeutic doses within 14 days prior to randomization.
• •17. Patients who had used therapeutic doses of other drugs for treating acid reflux within 7 days prior to randomization.
• •18. Patients required to continue receiving non-steroidal anti-inflammatory drugs (NSAIDs), systemic glucocorticoids, or clopidogrel during the trial period.
• •19. Patients whose assessment may be affected by alcohol, drug, or medication withdrawal during the study.
• •20. Pregnant or lactating women, as well as patients planning to conceive within 30 days before randomization and up to 6 months following the trial completion.
• •21. Patients who had participated in other drug clinical trials within 3 months prior to randomization.
• •22. Patients with other conditions deemed by the researchers as unsuitable for participation in this clinical trial.