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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001197
Receipt No. R000001461
Scientific Title Randomized control trial of primary eradication therapies of Helicobacter pylori
Date of disclosure of the study information 2008/07/01
Last modified on 2008/12/17

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Basic information
Public title Randomized control trial of primary eradication therapies of Helicobacter pylori
Acronym RAC versus LAC study
Scientific Title Randomized control trial of primary eradication therapies of Helicobacter pylori
Scientific Title:Acronym RAC versus LAC study
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 the RAC therapy and the LAC therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
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 Influence of the clarithromycin resistance of Helicobacter pylori and the CYP2C19 genotype of the host for the eradication thrapies

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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rabeprazole 10mg bid, amoxicillin 750mg bid and clarithromycin 200mg bid
Interventions/Control_2 lansoprazole 30mg bid, amoxicillin 750mg bid and clarithromycin 200mg bid
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who fills everything the following
1)Patients with gastric or duodenal ulcer
2)Patients infected by Helicobacter pylori, confirmed by bacterial culture test or rapid urease test or urea breath test
3)Patients of 20 years or more
4)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 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Akanuma
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411(33070)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masao Akanuma
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email makanuma@qd6.so-net.ne.jp

Sponsor
Institute University of Tokyo Hospital
Department of Gastroenterology
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
2008 Year 07 Month 01 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
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 17 Day
Last modified on
2008 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001461

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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