Reflux esophagitis
Conditions
Interventions
The control group:H008 blank tablets 2 tablets + lansoprazole enteric capsule 1 tablet, once a day
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects aged 18 years and <= 75 years are not limited in gender; 2. Within 7 days before randomization, the subjects were diagnosed with reflux esophagitis of Los Angeles (LA) Grade A to d by endoscopy (Note: the subjects with La grade C / D accounted for at least 20% of the total number of planned cases); 3. The subjects who can record the diary card independently; 4. Fully understand the content of the trial, volunteer to participate in the trial and be able to complete the trial process, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who had received H008 tablets in the past; 2. Subjects with known allergic history to H008 tablets or lansoprazole, or allergic to related excipients of H008 tablets or lansoprazole enteric coated capsules, such as mannitol, microcrystalline cellulose, cross-linked povidone, hydroxypropyl cellulose, magnesium stearate, film coating agent; 3. Subjects who could not accept upper gastrointestinal endoscopy; 4. Subjects with other organic lesions of esophagus except reflux esophagitis (except hiatal hernia, metaplasia columnar epithelium not involving the whole esophagus or short Barret esophagus less than 3cm in length) found by endoscopy; 5. Subjects with rheumatic immune diseases (such as scleroderma, undifferentiated connective tissue disease, etc.) that may affect esophageal motility, or with a history of esophageal radiotherapy or esophageal cryotherapy; 6. Subjects with acute upper gastrointestinal bleeding within 4 weeks before randomization; 7. Subjects with active peptic ulcer, suspected or confirmed malignant tumor found by upper gastrointestinal endoscopy; 8. Subjects known to have Zhuo AI syndrome, achalasia or inflammatory bowel disease; 9. Subjects who have had previous operations affecting the structure or function of esophagus, stomach or duodenum, or operations affecting gastric acid secretion; 10. Subjects who plan to undergo surgery that may affect gastric acid secretion (e.g., abdominal surgery, vagotomy, or craniectomy) during the study period; 11. Select the subjects who have a history of malignant tumor in the previous 5 years (if the subject's skin basal cell carcinoma or cervical carcinoma in situ has been cured, he / she can participate in this study); 12. Subjects with severe diseases of central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, and the researchers believe that the research results may be confused or the safety of the subjects may be affected; 13. Subjects with ALT or ast > 1.5 times of the upper limit of the normal value or renal function CR > the upper limit of the normal value in the screening period (one reexamination is allowed in the study, and those who still do not meet the inclusion requirements are excluded); 14. In the first 7 days of randomization, the subjects were treated with therapeutic doses of gastroesophageal reflux disease drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs (except hydrotalcite), gastrointestinal motility drugs and Chinese patent medicines for gastroesophageal reflux disease; 15. The subjects used nonsteroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors), systemic glucocorticoids, antiplatelet drugs (such as aspirin, clopidogrel, etc.) and anticoagulants (warfarin, etc.) for a long time before screening and could not be stopped during the trial; 16. The subjects who were using azanavir sulfate and lipivarin hydrochloride at the time of screening; 17. Subjects with a history of long-term drug abuse or alcohol abuse within 6 months before screening; 18. Subjects of women who are pregnant, lactating or preparing for pregnancy during the trial. According to the judgment of the researcher, the women of childbearing age who could not use the reliable contraceptive method approved by the medical department within 4 weeks after signing the inf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of reflux esophagitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heartburn, reflux; | — |
Countries
China
Contacts
Public ContactMinhu Chen, Yinglian Xiao
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed