non-erosive reflux disease
Conditions
Interventions
keverprazan 10mg:keverprazan 10mg, once a day, 8 weeks
keverprazan 20mg:keverprazan 20mg, once a day, 8 weeks
esomeprazole 20mg:esomeprazole 20mg, once a day, 8 weeks
Sponsors
The Eighth Affiliated Hospital, Sun Yat-sen University (Futian, Shenzhen)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Age 18-70 years old, gender not limited; ?The patient has the ability to understand and comply with protocol and agrees to participate in all study visits; ? The patient voluntarily sign a written informed consent approved by the Ethics Committee before any research procedure; ? When the patient complained of reflux and heartburn, other diseases that might cause the symptoms could be ruled out, and no esophageal mucosal erosion was found by endoscopy; ?In the last 3 weeks before the screening period began, the patient had recurrent heartburn symptoms at least 2 days per week; ?The fertile women agreed appropriate contraception throughout the study period.
Exclusion criteria
Exclusion criteria: ? The patients who have participated in any other clinical study within 3 months; ? The patients who have received acid suppression therapy (such as omeprazole, Rabeprazole, Lansoprazole, Tegoprazan, Vonoprazan, etc.); ? Barrett's esophagus, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, and esophageal stenosis; esophageal radiotherapy or cryotherapy history; corrosive or physicochemical esophageal trauma (e.g. esophageal sclerotherapy); ? Anti-reflux surgery, including fundus folding, dilation of esophageal stenosis, gastric or duodenal surgery (except endoscopic resection of benign polyps); ? Acute upper gastrointestinal bleeding, gastric or duodenal ulcer, acute gastric or duodenal mucosa injury within 30 days; ? Zollinger-Ellison syndrome or hypersecretion of gastric acid; ? The subjects had "warning" symptoms such as swallowing pain, severe dysphagia, bleeding, weight loss, anemia or hematochezia, which suggested the possibility of malignant gastrointestinal diseases, except those who were ruled out by endoscopy; ? The patients who cannot undergo upper gastrointestinal endoscopy; ? Allergic to keverprazan or esomeprazole (including preparations and excipients); ? Pregnant or lactating women; any serious liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system, or psychiatric disorders that may affect participant safety or interpretation of study results; ? Malignant tumor history within 5 years; ? Requiring hospitalization during the course of the study; ? Any of the following abnormal laboratory test results: AST > upper normal value, ALT > upper normal value, total bilirubin > upper normal value, creatinine > 1.5 times upper normal value; ? Clinically significant abnormal electrocardiogram, including severe arrhythmia, multifocal preventricular contraction (PVC), second degree and more severe atrioventricular block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of days without heartburn;Severity of heartburn;Change in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) score;Change in Gastroesophageal reflux disesae Health-Related Quality of Life (GERD-HRQL) questionnaire score; | — |
Countries
China
Contacts
Public ContactTing Zhou
The Eighth Affiliated Hospital, Sun Yat-sen University (Futian, Shenzhen)
Outcome results
None listed