gastric ulcer
Conditions
Interventions
Test group:Subjects will take oral Keverprazan hydrochloride tablets, 20 mg once daily, for a continuous period of 8 weeks.
control group:Subjects will take oral Esomeprazole, 20 mg once daily, for a continuous period of 8 weeks.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 and = 5 mm and 81 mg/day). The type and daily dose of NSAIDs must remain stable for at least 4 weeks prior to baseline endoscopy, and are expected to remain stable throughout the study. 4. Subjects who can independently complete the study diary card. 5. Subjects who fully understand the study procedures, voluntarily agree to participate, are able to comply with the study requirements, and have signed the informed consent form. 6. Subjects may be enrolled regardless of Helicobacter pylori infection status, and, according to current clinical guidelines, should receive standard eradication therapy when indicated.
Exclusion criteria
Exclusion criteria: 1. Individuals with small bowel haemorrhage, large bowel haemorrhage, or unexplained gastrointestinal bleeding; 2. Individuals with a history of surgery affecting gastric acid secretion (e.g., upper gastrointestinal resection, vagotomy) or those scheduled for such procedures; 3. Individuals with a past or current history of Zollinger-Ellison syndrome or other conditions involving excessive gastric acid secretion; 4. Individuals with allergies to capralicin, esomeprazole, or any excipients in the formulation; 5. Individuals with a history of chronic drug abuse or chronic alcoholism within one year prior to screening; 6. Pregnant, breastfeeding, or planning pregnancy; 7. Any severe neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urinary, endocrine, or haematological disease; 8. History of malignant neoplasms within five years prior to screening; 9. Subjects with abnormal laboratory findings (creatinine >2 mg/dL, aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 times the upper limit of normal (ULN), total bilirubin >2.0 times ULN); 10. Subjects deemed otherwise unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with healed NSAID-associated gastric ulcers;The relief rate of nausea; | — |
Secondary
| Measure | Time frame |
|---|---|
| The relief rate of upper abdominal pain;The relief rate of heartburn;The relief rate of acid reflux;The relief rate of emesis;The relief rate of belching;The relief rate of abdominal distension;Time to disappearance of upper abdominal pain symptoms;Time to disappearance of heartburn symptoms;Time to disappearance of acid reflux symptoms;Time to disappearance of nausea symptoms;Time to disappearance of emesis symptoms;Time to disappearance of belching symptoms;Time to disappearance of abdominal distension; | — |
Countries
China
Contacts
Public ContactXue Xiao
West China Hospital of Sichuan University
Outcome results
None listed