UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007632 |
|---|---|
| Receipt number | R000009007 |
| Scientific Title | Evaluation of third-line eradication for H. pylori infection in Japan |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/04/01 13:16:48 |
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Basic information
Public title
Evaluation of third-line eradication for H. pylori infection in Japan
Acronym
Third-line eradication of H. pylori
Scientific Title
Evaluation of third-line eradication for H. pylori infection in Japan
Scientific Title:Acronym
Third-line eradication of H. pylori
Region
| Japan |
Condition
Condition
The patients after unseccessful 1st and 2nd line eradicationtreatment
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find standard 3rd-line eradication regimen for H. pylori infection in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Eradication rate
Key secondary outcomes
Adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
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
LPZ30mgqid + AMPC500mgqid(2W)
Interventions/Control_2
LPZ 30mg bid + AMPC 750mg bid + LVFX 300mg bid (1W)
Interventions/Control_3
LPZ 30mg bid + AMPC 750mg bid + STFX 100mg bid (1W)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients after failure of 1st-line eradcation (PPI+AMPC+CAM) and 2nd-line eradcation (PPI+AMPC+MNZ)
Key exclusion criteria
a history of antimicrobials after 2nd-line eradcation
a history of PPI use 1 week before entry a history of NSAID or steriod use 1 month before entry
a history of gastrointestinal surgery,
the severe liver, renal, and cardiopulmonary dysfunctions
a history of drug allergy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo
TEL
81-11-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo
TEL
81-11-716-1161
Homepage URL
Sponsor or person
Institute
Japan Gast Study Group
Institute
Department
Personal name
Funding Source
Organization
Hiroshima cancer Seminer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
北海道大学病院、大分大学付属病院 その他21施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
The highest eradication rate was 70% in PPI based one-week triple therapy using AMPC and STFX.
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
| 2010 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 01 | Day |
Last modified on
| 2013 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009007
