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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000198
Receipt No. 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

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Basic information
Public title Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Acronym Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Scientific Title Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Scientific Title:Acronym Accelerative effect of polaprezinc on healing gastric ulcer after eradication of Helicobacter pylori infection
Region
Japan

Condition
Condition Gastric ulcer with Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes The time for healing of gastric ulcer
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key 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
Key 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
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Terano
Organization Dokkyo University School of Medicine
Division name President
Zip code
Address 880,Kitakobayashi,Mibu-mati,Shimotuga,Tochigi,321-0293,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Zeria Pharmaceutical Co.,LTD.
Division name Clinical Research
Zip code
Address 10-11,Nihonbashi,Kobuna-cho,Chuo-ku,Tokyo,103-8351,Japan
TEL
Homepage URL
Email kaihatu@zeria.co.jp

Sponsor
Institute Zeria Pharmaceutical Co.,LTD.
Institute
Department

Funding Source
Organization Zeria Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JapicCTI-050077
Org. issuing International ID_1 Japan Pharmaceutical Information Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2005 Year 05 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 11 Month 01 Day
Date trial data considered complete
2008 Year 11 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2008 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000251

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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