Duodenal ulcer
Conditions
Interventions
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 with active duodenal ulcer diagnosed by endoscopy were divided into A1 or A2 stages without active bleeding (Forrest grade II C or III was required for inclusion in this study); 3. Within 7 days before randomization, if the number of duodenal ulcer was 1-2, 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 can complete the diary card independently; 5. The subjects who fully understand the content of the trial, voluntarily participate in the trial and can 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 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. Subjects with complex ulcer confirmed by endoscopy within 7 days before randomization; 7. Subjects with active postoperative ulcer (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 and biopsy) within 1 month before screening (except biopsy for diagnostic purposes); 9. Subjects with Zolling Ellison syndrome, esophageal erosion or ulcer, esophageal or gastric varices; 10. Subjects with inflammatory bowel disease (Crohn's disease, ulcerative colitis) or previous history of inflammatory bowel disease; 11. Subjects with severe peptic ulcer complications (e.g., perforation, pyloric stenosis, duodenal stenosis, active bleeding) who cannot be treated with oral medication alone; 12. Subjects who have had previous operations affecting the structure or function of esophagus, stomach or duodenum, or operations affecting gastric acid secretion; 13. Subjects who plan to undergo surgery that may affect gastric acid secretion (e.g., abdominal surgery, vagotomy, or craniectomy) during the study period; 14. 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); 15. The subjects have serious 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. In the first 7 days of randomization, the subjects who used therapeutic doses of ulcer drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs (except hydrotalcite), gastrointestinal motility promoting drugs, and Chinese patent drugs for peptic ulcer; 19. The patients who had 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 were screened; 20. Pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The duodenal ulcer heals; | — |
Secondary
| Measure | Time frame |
|---|---|
| Upper abdominal pain, stomach burning, acid reflux, nausea, vomiting, belching and abdominal distension; | — |
Countries
China
Contacts
Public ContactMinhu Chen, Yinglian Xiao
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed