None listed
Conditions
Interventions
Drug : 1. Study drug
- Test drug: K-CAB tablet 50mg(tegoprazan), Nexium Tab 20mg(Esomeprazole) placebo
- Control drug: Nexium Tab 20mg(Esomeprazole), K-CAB tablet 50mg(tegoprazan) Placebo
2. Adminis
Sponsors
Konyang University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 19 years older at the time of signing the informed consent form 2. Patients who experienced typical gastroesophageal reflux disease (GERD) symptoms (heartburn or regurgitation) and experienced significant improvement in symptoms after using PPIs for at least 4 weeks (patients diagnosed with NERD and experiencing symptom improvement after treatment using PPIs) or patients diagnosed with erosive gastroesophageal reflux disease (ERD) on endoscopy and complaining of typical GERD symptoms, patients who experienced significant symptom improvement after using PPI for at least 8 weeks (diagnosed with ERD and experienced symptom improvement after treatment using PPI) 3. Able to understand and comply with instructions and able to participate in the study throughout the study period 4. Voluntary written informed consent to study participation 5. Consent to use of medically appropriate method of contraception (including medically sterile conditions) during the study. - Women under following medically sterile conditions may participate in this study: post-menopause (amenorrhea for at least 24 months), or sterilized via hysterectomy, tubectomy or bilateral oophorectomy. - Medically appropriate methods of contraception include intrauterine device (loop, Mirena®), physical barrier (male condom, female condom [femidom]), subcutaneous implantation (such as Implanon®), tubectomy, tubal ligation, and vasectomy; of note, injectable hormonal contraceptives and oral contraceptives are not permitted during the study and it is recommended to use dual contraceptive methods to avoid pregnancy during the study.
Exclusion criteria
Exclusion criteria: 1. Unable to undergo upper gastrointestinal endoscopy 2. Unable to complete a subject diary by oneself 3. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett’s esophagus with > 3 cm length (LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy 4. History of surgical procedures on the esophagus, stomach, or duodenum 5. Prior or planned surgery that might affect gastric acid secretion (e.g., upper gastrointestinal resection, vagotomy, etc.) - Simple surgery for perforation, appendectomy, cholecystectomy, and endoscopic resection of benign tumors are acceptable. 6. Is receiving HIV protease inhibitor (atazanavir, nelfinavir) or rilpivirine containing agent. 7. History of hypersensitivity to proton pump inhibitor and the ingredient of potassium-competitive acid blocker or the family of benzimidazoles. 8. History of malignancy within recent 5 years. - Note: Subjects who had CR or pCR without relapse within 5 years from the date of its confirmation and subjects whose tumor had been completely removed by endoscopic resection without recurrence of within 3 years are allowed. 9. Requirement of persistent use of NSAIDs during the course of study; - However, low dose (=100 mg/day) aspirin is allowed provided that it has been used for prophylaxis from prior to study participation. 10. Clinically significant disorders in the liver, kidney, cardiovascular system, respiratory system, endocrine system, or central nervous system 11. Clinically significant abnormalities at the clinical laboratory test within 3 months - BUN, creatinine levels >1.5 x institution-specific upper normal limit (UNL) - AST, ALT, ALP, ?-GT, total bilirubin levels >2 x institution-specific upper normal limit (UNL) 12. Is pregnant or breastfeeding. 13. Has a plan to undergo surgery or surgical procedure requiring hospitalization during the study. 14. Has participated in other clinical study and received another investigational agent within 12 weeks prior to Visit 1(date of screeing) Note: Current or previous participation in a study conducted in a non interventional fashion (such as observational study or survey) and thus considered to have no interference with the evaluation of efficacy and safety in the current study at the discretion of the investigator is not excluded. - Individuals who had provided informed consent to another clinical trial but were screening failures without having received any investigational product or undergone any procedures may also participate in this study. 15. Fails to obtain the informed consent of subject and guardian. 16. Has other clinically relevant conditions which render the subject ineligible for the study in the medical judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 8 weeks of On-demand therapy, the difference in overall satisfaction is compared with a 5-point Likert scale.;Safety endpoint(physical examination, vital signs, clinical laboratory test, adverse event) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time taken for symptoms to improve after administration;The number of study drugs taken during the On-demand therapy;The difference in the amount of change between two arms and within each arms using a 5-point scale for the intensity and frequency of heartburn and gastric acid reflux;The differences in overall satisfaction after 4 weeks of On-demand therapy | — |
Countries
Korea, Republic of
Contacts
Public ContactSeonmun Kim
Konyang University Hospital
Outcome results
None listed