To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;
Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.
Those who have experienced heartburn and reflux symptoms (with medical records) within 7 days before screening or who have been diagnosed with reflux esophagitis by endoscopic examination within 7 days before screening;
Screening period for upper gastrointestinal endoscopy, diagnosed with grade A-D reflux esophagitis in Los Angeles (those who have received endoscopic examination results from our center, have been judged by researchers to meet the diagnostic criteria, and have not been examined within 14 days before randomization, do not need to repeat this examination).
Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;
Those who cannot accept upper gastrointestinal endoscopy;
Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;
History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;
Parallel
JP-1366 simulation tablets
Drugqd, last for 4-8 weeks
Esomeprazole Magnesium (Nexium) simulation tablets
Drugqd, last for 4-8 weeks
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 4 weeks of treatment
Changes in the severity of major symptoms (heartburn and reflux) compared to the base line at 4 and 8 weeks after treatment.
Changes in the frequency of major symptoms (heartburn and reflux) compared to the base line at 4 and 8 weeks after treatment.
Changes in the overall score of gastroesophageal reflux disease health-related quality of life (GERD-HRQL) compared to the base line at 4 and 8 weeks after treatment
evalutated by Gastroesophageal reflux disease health-related quality of life(GERD-HRQL), the value is \[-50,0\] and the lower score means better outcome.
Percentage of subjects without major symptoms (heartburn and reflux) occurring within 1 week, 4 weeks, and 8 weeks after treatment (day, night, day, and night).
Percentage of days without major symptoms (heartburn and reflux) occurring within 1 week, 4 weeks, and 8 weeks after treatment (day, night, day, and night)
The first time there were no major symptoms (heartburn and reflux) for 7 consecutive days after treatment
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