Phase IV, multi-center, randomized, open-labeled, comparison study
Conditions
Interventions
Intervention group is treated by rebamipide and esomeprazole
Control group is treated by esomeprazole
Sponsors
Korean College of Helicobacter and Upper Gastrointestinal Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged over 20 years and less 70 years 2) Patients diagnosed as reflux esophagitis through esophagogastroduodenoscopy 3) Patients signing the informed consent document of this clinical study
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women, child bearing women not using a proper contraception 2) Patients with history of gastrointestinal surgery 3) Patients with gastric ulcer or duodenal ulcer 4) Patients with significant impairment in the heart, the lung, the blood or the endocrine system 5) Patients with psychiatric disorders or alcohol or drug addiction 6) Patients who are considered to be unsuitable by investigator(s) because of other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of a total symptom score after four-week administration of esomeprazole and rebamipide | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean decrease in the total symptom score at 4 weeks since trial medicine, the change from baseline of reflux symptoms (heartburn and regurgitation), the proportion of patients with at least a 50% decrease in the symptoms score compared with their baseline score, and the proportion of patients reporting complete improvement of symptoms | — |
Countries
Asia(except Japan)
Contacts
Public ContactSu Jin Hong
Soonchunhyang University College of Medicine, Seoul, Korea Department of Internal Medicine
Outcome results
None listed