Refractory reflux esophagitis
Conditions
Interventions
treatment group:Keverprazan, 20mg, QD
Maintenance group:Keverprazan, 10mg, QD
Surgical group:Fundoplication
Sponsors
Zhejiang Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1: Age = 20 years old, no gender limit 2: Failure to control symptoms despite continued regular treatment with conventional (or higher) doses of proton pump inhibitors 3: Previous diagnosis of reflux esophagitis 4: Percentage of time with lower esophageal pH 4.2% 5: Subjects who can independently complete subject diary card 6: Subjects who fully understand the content of the trial, volunteer to participate in the trial and are able to complete the trial process, and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1: Subjects with endoscopic findings of organic esophageal pathology other than reflux esophagitis (with the exception of esophageal hiatal hernia, pyogenic columnar epithelium that does not involve the full perimeter of the esophagus, or short segments of Barrett's esophagus <3 cm in length) 2: Previous history of esophageal or gastric surgery 3: Subjects with diagnosed or suspected upper gastrointestinal malignancy 4: Previous use of P-cabs such as Keverprazan 5: Subjects with known Drewe-Ayer syndrome, primary dyskinesia, esophageal stenosis, pancreatic achalasia, or inflammatory bowel disease (IBD) 6: Subjects with severe systemic diseases, major organ such as heart, lung and brain diseases, liver and kidney insufficiency, malignant tumors or other diseases 7: Subjects with psychiatric disorders such as severe depression and anxiety tendencies who are unable to complete the experiments 8: Subjects who known hypersensitivity to Keverprazan and its related excipients (e.g., mannitol, microcrystalline cellulose, cross-linked polyvinyl ketone, hydroxypropyl cellulose, magnesium stearate, etc.) 9: Pregnant or lactating women 10: Subjects with chronic alcoholism or any other increased risk of adverse treatment effects 11: Subjects who have participated in other studies within 3 months and who are unable to express themselves correctly or who are unable to cooperate with the investigators 12: Other patients considered by the investigators to be unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of esophageal acid exposure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastroesophageal Reflux Disease Questionnaire(GERD-Q) score;Gastroesophageal reflux disesae Health-Related Quality of Life questionnaire score;Hospital Anxiety and Depression Scale score;Esophagitis score and healing rate; | — |
Countries
China
Contacts
Public ContactZhifei Wang
Zhejiang Provincial People’s Hospital
Outcome results
None listed