None listed
Conditions
Interventions
Drug : 4 weeks, Oral administration.
Experimental: Fexuprazan 40 mg before breakfast + Esomeprazole 40 mg placebo before breakfast + Nizatidine 150mg placebo before bedtime
Comparator1: Fexuprazan 40
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Individuals aged 19 or older but less than 75 as of the date of obtaining of written consent 2. Individuals diagnosed with LA grade A or B erosive gastritis or non-erosive gastroesophageal reflux disease based on an upper gastrointestinal endoscopy (EGD) conducted at Visit 1 or within 3 months of Visit 1. who fulfill both of the following criteria ? Individuals who have demonstrated therapeutic response to a Proton Pump Inhibitor (PPI) used for the treatment of previous gastroesophageal reflux disease, having been treated with a PPI for 2 weeks or more, but still experiencing night reflux symptoms. ? Individuals with a GERD-Q(GERD-Q: Gastroesophageal Reflux Disease Questionnaire) score of 8 or higher at Visit 2 who have experienced heartburn or acid regurgitation for one or more days in the past 7 days 3. Individuals who have complained of nighttime heartburn or acid regurgitation since at least 3 months prior to Visit 1(Screening) 4. Individuals who can comprehend and adhere to instructions and are able to participate throughout the entire period of the study. 5. Individuals who have voluntarily decided to participate and consent on the clinical trial consent form 6. Individuals who agree to use medically acceptable methods of contraception (including medically sterile state) during the duration of the study. -Women who are medically incapable of pregnant are eligible to participate in this study. : Menopause (more than 24 months amenorrhea), hysterectomy, tubectomy, oophorectomy, etc. - medically acceptable methods of contraception: Intrauterine device (Loop, Mirena), barrier methods (male condoms and female condoms(Femidom), contraceptive inplants (Implanon, etc.), contraceptive injections or tubectomy, tubal ligation, vasectomy, etc. (Oral contraceptive pills are not permitted for use during this clinical trial, and it is recommended to use dual contraception to prevent pregnancy during participation in this trial.
Exclusion criteria
Exclusion criteria: 1. Individuals for whom upper gastrointestinal endoscopy is contraindicated. 2. Individuals who are unable to independently complete the clinical trial diary 3. Individuals with esophageal stricture, ulceration, esophageal varices, Barrett's esophagus (greater than 3 cm), eosinophilic esophagitis, active peptic ulcer disease, or gastrointestinal bleeding detected during upper gastrointestinal endoscopy 4. Individuals with warning symptoms suggestive of malignancy in the gastrointestinal tract, such as dysphagia, severe dyspepsia, bleeding, weight loss, anemia, or melena 5. Individuals with primary or secondary esophageal motility disorders confirmed . 6. Individuals who have undergone or are planning to undergo surgery that may affect gastric acid secretion (e.g., surgical upper gastrointestinal resection, vagotomy, etc.), except for those who have undergone simple perforation surgery, appendectomy, cholecystectomy, or endoscopic resection of benign tumors. 7. Individuals diagnosed with or suspected of functional dyspepsia (FD), primary esophageal motility disorders, irritable bowel syndrome (IBS), or inflammatory bowel disease (IBD) within the last 3 months. 8. Individuals with a history of hypersensitivity reactions to components of antacids, proton pump inhibitors, potassium-competitive acid blockers, or benzimidazoles. 9. Individuals with a history of malignancy within the past 3 years, except those who have diagnosed with complete response (CR, pCR) and have been recurrence-free for over 5 years from the diagnosed date or have undergone endoscopic resection of the tumor with no recurrence for over 3 years. 10. Individuals with clinically significant impairments in the liver, kidney, cardiovascular, respiratory, endocrine, or central nervous systems. 11. Individuals who have shown clinically significant abnormal values in screening tests - AST, ALT, ALP, ?-GT, total bilirubin = twice the upper limit of normal. 12. Pregnant or lactating women. 13. Individuals with a history of drug or alcohol abuse within the past year. 14. Individuals who have taken acid suppressants within 2 weeks of Visit 2 (randomization). 15. Individuals who have taken medications for the treatment of gastroesophageal reflux disease(H2 receptor antagonists, Prostaglandins, Mucosal protective agents, Prokinetics, Antacids, etc.) within 1 week of Visit 2 (randomization), exceeding twice the recommended dose. 16. Individuals receiving HIV protease inhibitors (atazanavir, nelfinavir), rilpivirine-containing formulations, or tetracycline antibiotics. 17. Individuals with genetic issues such as galactose intolerance. 18. Individuals scheduled for surgery requiring hospitalization or surgical treatment during the clinical trial period. 19. Individuals working night shifts (midnight ~ 6 a.m.). 20. Individuals with scheduled flights crossing three or more time zones according to Universal Time Coordinated (UTC) during the clinical trial period. 21. Individuals who have participated in another clinical trial within 4 weeks of Visit 1 (screening day), except for those who have participated in or are participating in non-interventional studies (observational studies, survey studies, etc.) that are judged not to affect the efficacy and safety assessment of this trial or those who were disqualified from screening for another clinical trial after signing the informed consent form for participation in another clinical trial without administration of investigational drugs or pro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of days without nighttime chest discomfort during the 4-week medication period | — |
Secondary
| Measure | Time frame |
|---|---|
| The interval to the first time without nighttime chest discomfort (days);The percentage of days without daytime chest discomfort during the medication period;Improvement in sleep disturbance due to nighttime chest discomfort symptoms during the first 7 days of the medication period;Average change in GSRS score after 2 weeks compared to baseline;Average change in KESS score after 2 weeks compared to baseline;The percentage of subjects whose sleep disturbances due to nighttime chest discomfort improved during the first 7 days of the dosing period.;Average change in GERD-QoL score after 2 weeks compared to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactYu Kyung Cho
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed