Gastroesophageal reflux disease
Conditions
Interventions
Tegoprazan Continuous Maintenance + On-demand Therapy Group:Weeks 1-8: Tegoprazan Tablets (Taixinzan), 50 mg, qd
Weeks 9-16: Take one tablet (50 mg) when symptoms occur, with a maximum of one tablet p
Tegoprazan On-demand Therapy Group:Weeks 1-16: Take one tablet (50 mg) when symptoms occur, with a maximum of one tablet per day.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, inclusive. 2. Confirmed by endoscopy within the past 6 months as having mild reflux esophagitis (LA grade A/B) OR endoscopy-negative but with typical reflux symptoms (heartburn, regurgitation, etc.) occurring >=2 times/week and a GerdQ score >=8. 3. Have received standard-dose PPI initial therapy for 4-8 weeks. 4. Voluntarily participate in the study and sign the informed consent form. If a subject is unable to read or sign due to incompetence, a legal guardian must proxy the informed consent process. If a subject is illiterate, an impartial witness must witness the process.
Exclusion criteria
Exclusion criteria: 1. Non-responders to initial PPI therapy. 2. Presence of peptic ulcer or gastrointestinal malignancy. 3. Conditions such as eosinophilic esophagitis, esophageal varices, esophageal stricture, esophageal viral/fungal infection, history of corrosive/physicochemical injury, history of esophageal radiotherapy, functional heartburn, or functional dyspepsia. 4. Pregnant or lactating women. 5. History of upper gastrointestinal surgery. 6. Severe primary diseases affecting the heart, brain, liver, lungs, kidneys, hematopoietic system, or endocrine system. 7. Severe mental illness not adequately controlled (e.g., inability to take medication on time or cooperate with follow-up). 8. Abnormal liver function (AST or ALT >1.5 times the upper limit of normal). 9. Known allergy to tegoprazan. 10. Requiring use of atazanavir, nelfinavir, or rilpivirine. 11. Any other reason deemed by the investigator to make the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GERD Health-Related Quality of Life (GERD-HRQL) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastroesophageal Reflux Disease questionnaire(GERD-Q);Proportion of subjects maintaining mucosal healing at Week 16;Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) Score; | — |
Countries
China
Contacts
Public ContactYurong Tang
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed