None listed
Conditions
Interventions
Drug : If the test subject agrees to participate in the clinical trial, the screening number is given and the screening test results of the test subject are assessed. A randomization number is assigne
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Only adult men and women over 19 years old 2) Within the last 14 days, based on Visit 1, those with typical symptoms (heartburn or reflux) at least twice a week 3) Anyone who understands the information provided to him/her and who can understand and write the questionnaire 4) Those who have decided to voluntarily participate in this clinical trial and have agreed in writing
Exclusion criteria
Exclusion criteria: 1) A person who shows signs of severe or malignant diseases including unintended weight loss, hematemesis, hematochezia, or jaundice 2) Within the last 3 months on Visit 1, upper gastrointestinal endoscopy shows pyloric stenosis, peptic ulcer (except for ulcer scar), Barrett's esophagus (3 cm or more), gastrointestinal varices, or gastrointestinal bleeding, 3) Those with primary esophageal motility disorders, pancreatitis, absorption disorders, inflammatory bowel diseases (Crohn's disease, ulcerative colitis, etc.), or irritable bowel syndrome 4) Patients with Zolinger-Ellison syndrome 5) Patients with eosinophilic esophagitis 6) Those who have been diagnosed with severe pulmonary disease within the last 3 months 7) Patients with severe liver dysfunction or liver disease (serum ALT, AST, GGT, total bilirubin more than twice the normal upper limit) 8) Patients with chronic renal disease or severe renal disease including renal dysfunction (serum BUN, creatinine more than twice the normal upper limit) 9) Uncontrolled diabetes, cerebrovascular disease 10) Patients who underwent surgery during the last 3 months 11) Those with a history of malignant tumors within 5 years 12) Persons with psychological illness, drug or alcohol abuse 13) Those who have hypersensitivity reactions to medicines for clinical trials, drugs including esomeprazole, and other drugs (benzimidazoles, antibiotics, etc.) 14) Those who took PPI within 28 days of Visit 1 15) Those who took Histamine H2 blocker, sucralfate, gastrointestinal exercise promoter, or antacid within 14 days of visit 1 16) Pregnant women, lactating women or women who have not agreed to the appropriate use of contraception during the trial (? Proper contraceptive method: Condoms, oral contraceptives, injecting contraceptives for injection or use, intrauterine contraceptive devices, etc.) 17) Those who have received other clinical trial drugs within 3 months from the written consent 18) A person who is deemed not to be suitable for the clinical trial as determined by the tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects whoes gastroesophageal reflux symptoms are subsided | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects whoes gastroesophageal reflux symptoms are subsided;Evaluation of quality of life through GERD-Health Related Quality of Life | — |
Countries
Korea, Republic of
Contacts
Public ContactGwang Ha Kim
Pusan National University Hospital
Outcome results
None listed