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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003074
Receipt No. R000003729
Scientific Title Randomized control trial of secondary eradication therapies of Helicobacter pylori
Date of disclosure of the study information 2010/01/21
Last modified on 2010/01/21

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Basic information
Public title Randomized control trial of secondary eradication therapies of Helicobacter pylori
Acronym Secondary eradication therapies of Helicobacter
Scientific Title Randomized control trial of secondary eradication therapies of Helicobacter pylori
Scientific Title:Acronym Secondary eradication therapies of Helicobacter
Region
Japan

Condition
Condition Gastroduodenal ulcer infected by Helicobacter pylori
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and the safety of Helicobacter pylori secondary therapies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of the Helicobacter pylori eradication on the bassis of the urea breath test result
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rabeprazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
Interventions/Control_2 lansorazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
Interventions/Control_3 omeprazole 10mg bid, amoxicillin 750mg bid and metronidazole 250mg bid
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who fills everything the following
1)Patients with gastric or duodenal ulcer
2)Patients of primary eradication failure
3)Patients infected by Helicobacter pylori, confirmed by bacterial culture test or rapid urease test or urea breath test
4)Patients of 20 years or more
5)Patients who gives written informed consent
Key exclusion criteria 1)Pregnant females
2)Lacting woman
3)Patients who has past history of allergy for the drugs used in this study
4)Patients who has coexisting severe disease
5)Patient whom examination doctor judged improper as testee
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Maeda
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

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
Homepage URL
Email

Sponsor
Institute University of Tokyo Hospital
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
2010 Year 01 Month 21 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 Open public recruiting
Date of protocol fixation
2008 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 21 Day
Last modified on
2010 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003729

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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