UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000578 |
|---|---|
| Receipt number | R000000703 |
| Scientific Title | Second-line and third-line treatment after unsuccessful H. pylori eradication |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2009/07/22 11:42:04 |
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Basic information
Public title
Second-line and third-line treatment after unsuccessful H. pylori eradication
Acronym
Second-line and third-line H. pylori eradication treatment
Scientific Title
Second-line and third-line treatment after unsuccessful H. pylori eradication
Scientific Title:Acronym
Second-line and third-line H. pylori eradication treatment
Region
| Japan |
Condition
Condition
H. pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of metronidazole-based and gatifloxaci-based triple therapy as H.pylori eradication regimen
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
eradication rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Second-line regimen
lansoprazole 60mg 2x
amoxicillin 1500mg 2x
metronidazole 750mg 2x (500-250)
Interventions/Control_2
Third-line regimen
rabeprazole 40mg 4x
amoxicillin 2000mg 4x
gatifloxacin 400mg 1x
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had one or two treatment failures (first-line treatment used: triple therapy with PPI-AMX-CLR for 7 days; second-line treatment used; triple therapy with PPI-AMX-MNZ for 7 days)
Key exclusion criteria
allergy to drugs stated in protocol or pregnncy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nisizawa@f7.so-net.ne.jp
Sponsor or person
Institute
Department of Internal Medicine,
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine,
Keio University School of Medicine
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
| 2007 | 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
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
| 2004 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 22 | Day |
Last modified on
| 2009 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000703
