Reflux Esophagitis
Conditions
Interventions
Control group:During the on-demand treatment phase, patients should take esomeprazole tablets when they experience symptoms. The dosage is 20mg per time (one tablet, with a maximum of one tablet per d
Experimental group:During the on-demand treatment phase, patients take tegololisine tablets when they experience symptoms. The dosage is 50mg per time (one tablet, with a maximum of one tablet per day
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years (inclusive); 2. Patients who have been diagnosed with mild reflux esophagitis (Los Angeles classification A/B grade) by endoscopy within the past 6 months and have concurrent substernal burning sensation (heartburn) or reflux symptoms, and whose symptoms have been relieved after completing the standard dose of PPI (8 weeks) or P-CAB (4 - 8 weeks) initial treatment; 3. Have signed the informed consent form; 4. Patients have agreed to use appropriate medical methods for contraception from the time of signing the informed consent form until 28 days after being discharged from the study. (This does not include women in a medically sterilized state.)
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Those who are known to be allergic to the drugs used in the study (including both the treatment group and the control group), or to their active ingredients and excipients; 3. Patients with moderate to severe liver dysfunction and any level of renal dysfunction; 4. Patients who are unable to take oral medications; 5. Patients who are unable to complete the medication log card (either electronic or paper-based); 6. Patients who have been diagnosed with malignant tumors of the esophagus and stomach; 7. Patients who the researcher deems unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retrosternal burning sensation (heartburn);Reflux symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom remission rate;Number of tablets taken;Number of days with retrosternal burning sensation (heartburn) or reflux symptoms;Safety data;Gastroesophageal Reflux Disease Health Related Quality of Life;Patient satisfaction;Percentage of patients with complete remission of retrosternal burning sensation (heartburn) and reflux symptoms, with no further episodes within 24 hours;Reflux Disease Questionnaire;Number of days of symptom relief;Median time to remission of retrosternal burning sensation (heartburn) and reflux symptoms; | — |
Countries
China
Contacts
Public ContactJingyuan Fang;Yingxuan Chen
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed