duodenal ulcer
Conditions
Interventions
control:Omeprazole Magnesium Enteric-coared Tablets
Text:Compound omeprazole dry suspension
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Diagnosed with active duodenal ulcer (active stage) in endoscopy, a week before treatment, with or without relative symptoms like upper abdominal pain/discomfort, sour regurgitation, heartburn, abdominal distension, and belching; 3. Ulcer diameters: 0.3-2.0cm; ulcer numbers: <=2; 4. Withdrawl of acid-suppressive drugs more than 2 weeks before this study, ulcer symptoms conform with diagnostic criteria; 5. Understanding and willing to attend this study with signed ICF.
Exclusion criteria
Exclusion criteria: 1. Still using drugs which can lead to an ulcer, like NSAID and Glucocorticoid; 2. Patients with anaphylactic and idiosyncrasy reaction for: the trail drug,the control drug, excipient, or any other Benzimidazole; 3. Carcinelcosis, ulcer with canceration tendency(including mild atypical hyperplasia of mucosa epithelium cell), compound ulcer; 4. Patients who has symptoms of serious and progressive dysphagia, weight loss, and gastrointestinal bleeding; 5. esophageal and gastric varices, zollinger-Ellisonsyndrome, serious complication like pyloric obstructionactive bleeding in endoscopy, pyloric stenosis hinder the endoscopy, esophageal erosion or ulcer, other serious digestive tract diseases like Crohn's diseaseUC(ulcerative?colitis); 6. History of gastric acid suppression operation (except for suture of perforation), esophageal operation or digestive organ surgery; 7. Female patients who are in lactation,pregnancy, or schedule for pregnancy; 8. Patients who have serious heart, liver, lung, kidney, blood diseases and endocrine system diseases,state of which is not under control (TBIL is more than 1.5 times ULN; ALT and AST are more than 1.5 times ULN; CR > ULN); 9. Participation in other trails in last 3 months; 10. Patients who need to use anti-ulcer drugs out of stipulations; 11. Drug and/or alcohol abusers; 12. Patients who should be limited in sodium, with metabolic alkalosis and hypocalcemia; 13. Long-term use of clopidogrel; 14. Other conditions unsuitable for this trail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Under gastroscope ulcer healing efficiently; | — |
Countries
China
Contacts
Public ContactShourong Shen
The Third Xiangya Hospital of Central South University
Outcome results
None listed