Duodenal ulcer
Conditions
Interventions
H008 Low dose group:H008 tablet 10mg (2 tablets) + H008 tablet simulant (1 tablet) + lansoprazole enteric capsule simulant (1 tablet), qd
H008 high dose group:H008 tablets 10mg (3 tablets) + lansoprazole enteric capsule simulation (1 tablet), qd
The control group:H008 tablets (3 tablets) + lansoprazole enteric capsule 30mg (1 tablet), qd
Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 years old, regardless of gender; 2. Within 7 days before randomization, the subjects who were diagnosed as active duodenal ulcer by endoscopy, with ulcer stage A1 or A2 under endoscopy and without active bleeding (Forrest grade II C or III is required for inclusion in this study); 3. Within 7 days before randomization, those subjects with 1-2 duodenal ulcer showed by endoscopy, the maximum diameter of ulcer was less than or equal to 2.0cm, and at least one ulcer was more than or equal to 0.3cm, the ulcer should have no scar tissue; 4. The subjects who fully understand the content of the trial voluntarily participate in the trial 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 with duodenal ulcer diagnosed as duodenal malignant tumor or with malignant tumor by endoscopy within 7 days before randomization; 4. The subjects with acute gastroduodenal mucosal lesions (agdml) confirmed or suspected by endoscopy within 7 days before randomization; 5. Subjects with linear duodenal ulcer confirmed by endoscopy within 7 days before randomization (including linear scar ulcer); 6. Patients with compound ulcer confirmed by endoscopy within 7 days before randomization; 7. Patients with active postoperative ulcers (e.g. endoscopic mucosal resection / endoscopic mucosal dissection) diagnosed by endoscopy within the first 7 days were randomly divided into two groups; 8. Subjects who had undergone therapeutic upper gastrointestinal endoscopy (e.g. endoscopic hemostasis, tissue resection biopsy) within 1 month before screening (except biopsy for diagnostic purposes); 9. Complicated with Zolling Ellison syndrome, esophageal erosion or ulcer, esophageal or gastric varices; 10. Patients with history of inflammatory bowel disease (Crohn's disease, ulcerative colitis); 11. Patients with severe peptic ulcer complications (e.g., perforation, pyloric stenosis, duodenal stenosis, active bleeding) and subjects who cannot only use oral drugs to treat ulcer; 12. Patients with previous digestive tract surgery, except for endoscopic polypectomy, endoscopic mucosal resection or endoscopic mucosal dissection of non duodenal bulb; 13. Patients who plan to undergo surgery that may affect gastric acid secretion (e.g., abdominal surgery, vagotomy, or craniectomy) during the study period; 14. A subject with a history of malignant tumor, or received malignant tumor treatment within 5 years before screening (if the subject's skin basal cell carcinoma or cervical carcinoma in situ has been cured, he / she can participate in this study); 15. Patients 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; 16. Subjects with ALT or ast > 1.5 times of the upper limit of normal value, or renal function CR > the upper limit of normal value in screening period (One review is allowed in the study, and those who still do not meet the inclusion requirements are excluded.) 17. Subjects who had received Helicobacter pylori eradication therapy within 1 month before randomization; 18. Subjects who had used therapeutic dose of ulcer drugs within 7 days before randomization, such as proton pump inhibitor (PPI), histamine H2 receptor antagonist (H2RA), mucosal protective drugs (except hydrotalcite), and Chinese patent medicine for peptic ulcer; 19. Patients who used NSAIDs, systemic glucocorticoids, antiplatelet drugs (such as aspirin, clopidogrel, etc.) and anticoagulants (warfarin, etc.) for a long time before the trial and could not be stopped during the trial; 20. Patients who were using azanavir sulfate and lipivarin at the time of screening; 21. Su
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Upper abdominal pain, stomach burning, acid reflux, nausea, vomiting, belching and abdominal distension; | — |
Primary
| Measure | Time frame |
|---|---|
| The duodenal ulcer heals; | — |
Countries
China
Contacts
Public ContactMinhu Chen, Yinglian Xiao
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed