UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002087 |
|---|---|
| Receipt number | 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 16:52:46 |
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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
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
kmabe@kkr-smc.com
Sponsor or person
Institute
Yamagata Clinical Helicobacter pylori study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002547
