UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000198
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

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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 or person

Institute

Zeria Pharmaceutical Co.,LTD.

Institute

Department

Personal name



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

Value
https://center6.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