Gastric ulcer with Helicobacter pylori infection
Conditions
Interventions
Patients in the treatment group are administered an antibiotic combination consisting of lansoprazole 30mg bid, clarithromycin 400mg bid and amoxicillin 750mg bid for one week. After that, they are gi
Sponsors
Zeria Pharmaceutical Co.,LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with active gastric ulcer 2)Patients with single gastric ulcer 3)Patients whose diameter of ulcer is 5 mm or longer 4)Patients who are judged Helicobacter pylori(+)ve with rapid urease test and urea breath test Other criteria 5)Patients whose age is 20 years or older but less than 80 years old at the time of obtaining informed consent 6)Outpatients 7)Patients who can understand the contents of this trial is obtained in written form
Exclusion criteria
Exclusion criteria: 1)The patients who have eradication therapy of Helicobacter pylori infection 2)Patients with liner ulcer, perforate ulcer, postoperative ulcer and duodenal ulcer as complication 3)Patients with gastrectomy, doudenectomy or vagectomy as previous illness 4)Patients with hemorrhagic ulcer or patients who expect flooding 5)Patients with acute ulcer which depth is superficial as an acute gastric mucusal lesion by other drugs, alcohol and so on 6)Patients who showed resistance to medical treatment although proton pomp inhibiter and histamine 2 receptor antagonist 7)Patients with serious cardiovascular disease, liver disease, kidney disease and hemodyscrasia. Here,''seriousness'' is to be a case corresponds to Grade 3 or higher Grade in ''Concerning classification criteria for seriousness of adverse drug reactions of medical agents''. 8)Patients who take steroid or anti-steroid inflammatory drugs. But no restriction for external drugs excluding suppository. 9)Patients who take proton pomp inhibiter, histamine 2 receptor antagonist, muscarine 1 receptor antagonist within 7days before initiation of the study drug 10)Patients who contraindicate lansoprazole, clarithromycin and amoxicillin or who are serious allergy to medicines 11)Patients who medication of a disinfection treatment is less than 12 times 12)Pregnant, females who suckles, or females who wish to become pregnant 13)Patients with malignant tumor as complication 14)Patients who are administered some kinds of clinical study within 3 months before obtaining informed consent 15)Others, patients who are judged to be inadequate to participate in this trial by the principal investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time for healing of gastric ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| The healing rate of gastric ulcer The evaluation of quality of ulcer healing The improvement rate of symptom The incidence of adverse events The incidence of adverse drug reactions | — |
Countries
Japan
Outcome results
None listed