UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001434 |
|---|---|
| Receipt number | R000001686 |
| Scientific Title | Clinical trial on efficacy and safety of eradication therapy for Helicobacter pylori infection to prevent gastric cancer. |
| Date of disclosure of the study information | 2008/10/20 |
| Last modified on | 2008/10/17 09:50:08 |
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Basic information
Public title
Clinical trial on efficacy and safety of eradication therapy for Helicobacter pylori infection to prevent gastric cancer.
Acronym
Helicobacter eradication for gastric cancer prevention.
Scientific Title
Clinical trial on efficacy and safety of eradication therapy for Helicobacter pylori infection to prevent gastric cancer.
Scientific Title:Acronym
Helicobacter eradication for gastric cancer prevention.
Region
| Japan |
Condition
Condition
atrophic gastritis with H. pylori infection
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to investigate efficacy and safety in long term of Helicobacter eradication for prevention of gastric cancer in the pateints with atrophic gastritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastirc cancer diagnosed by endoscopy
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Eradication therapy for H. pylori infection
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. positive for H. pylroi infection
2. atrophic gastritis by endoscopy
Key exclusion criteria
1. gastric malignancies or gastric adenomas
2. gastroduodenal ulcers
3. allergy for medicine used in this study
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Ogura |
Organization
University of Tokyo
Division name
Clinical Research Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology
University of Tokyo
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
| 2008 | Year | 10 | Month | 20 | 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
Date of protocol fixation
| 2008 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 17 | Day |
Last modified on
| 2008 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001686
