Unique ID issued by UMIN | C000000198 |
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Receipt number | R000000251 |
Scientific Title | Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2008/12/09 09:30:24 |
Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Japan |
Gastric ulcer with Helicobacter pylori infection
Gastroenterology |
Others
NO
The aim of this clinical trial is to assess the efficacy of polaprezinc to placebo on healing period for patients with gastric ulceration, after eradication of Helicobacter pylori infection
Safety,Efficacy
Confirmatory
Phase IV
The time for healing of gastric ulcer
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
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.
20 | years-old | <= |
79 | years-old | >= |
Male and Female
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
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
300
1st name | |
Middle name | |
Last name | Akira Terano |
Dokkyo University School of Medicine
President
880,Kitakobayashi,Mibu-mati,Shimotuga,Tochigi,321-0293,Japan
1st name | |
Middle name | |
Last name |
Zeria Pharmaceutical Co.,LTD.
Clinical Research
10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan
kaihatu@zeria.co.jp
Zeria Pharmaceutical Co.,LTD.
Zeria Pharmaceutical Co.,LTD.
Profit organization
Japan
YES
JapicCTI-050077
Japan Pharmaceutical Information Center
2005 | Year | 09 | Month | 13 | Day |
Unpublished
Completed
2005 | Year | 03 | Month | 18 | Day |
2005 | Year | 05 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2005 | Year | 09 | Month | 13 | Day |
2008 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000251
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