Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection

UMIN ID: C000000198

Registered date:13/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastric ulcer with Helicobacter pylori infection
• Date of first enrollment: 2005/05/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 given polaprezinc 75mg bid for twelve weeks.
Patients in the control group are administered an antibiotic combination consisting of labsoprazole 30mg bid, clarithromysin 400mg bid and amoxicillin 750mg bid for one week. After that, they are given placebo for twelve weeks.

Outcome(s)

• Primary Outcome: The time for healing of gastric ulcer
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Zeria Pharmaceutical Co.,LTD.
• Source(s) of Monetary Support: Zeria Pharmaceutical Co.,LTD.
• Secondary ID(s): JapicCTI-050077