UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001197 |
|---|---|
| Receipt number | 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 13:12:26 |
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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)
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
makanuma@qd6.so-net.ne.jp
Sponsor or person
Institute
University of Tokyo Hospital
Department of Gastroenterology
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001461
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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