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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002087
Receipt No. R000002547
Scientific Title Yamagata Clinical Helicobacter pylori study group
Date of disclosure of the study information 2009/06/17
Last modified on 2009/06/17

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Basic information
Public title Yamagata Clinical Helicobacter pylori study group
Acronym Yamagata Study
Scientific Title Yamagata Clinical Helicobacter pylori study group
Scientific Title:Acronym Yamagata Study
Region
Japan

Condition
Condition peptic ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of H. pylori eradication therapy for treatment of peptic ulcer on the incidence of gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incident rate ratio (IRR) of gastric cancer between patients receiving and not receiving H. pylori eradication therapy until end of 2007.
Key secondary outcomes The accumulated incidences of gastric cancer in patients with successful and unsuccessful H. pylori eradication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 H. pylori eradication therapy consisted of lansoprazole 30 mg or omeprazole 20 mg, plus amoxicillin 750 mg and clarithromycin 200 or 400 mg all twice daily for 7 days.
Interventions/Control_2 Conventional antacid therapy consisted of antacids such as proton-pump inhibitors (PPIs) and histamine-H2 blockers for 6 or 8 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
12 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with H. pylori-positive peptic ulcer were considered eligible.
Key exclusion criteria Patients with a history of gastric cancer and those in whom endoscopy or biopsy at the time of registration revealed gastric cancer were excluded from the study.
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiro Mabe
Organization KKR Sapporo Medical Center
Division name Gastroenterology
Zip code
Address Hiragishi 1-6,Toyohira-ku,Sapporo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiro Mabe
Organization KKR Sapporo Medical Center
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email kmabe@kkr-smc.com

Sponsor
Institute Yamagata Clinical Helicobacter pylori study group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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
2000 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2000 Year 11 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 04 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 17 Day
Last modified on
2009 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002547

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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