UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004778 |
|---|---|
| Receipt number | R000005689 |
| Scientific Title | Efficacy of sitafloxacin as third-line eradication treatment of Helicobacter pylori |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2014/10/01 11:56:16 |
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Basic information
Public title
Efficacy of sitafloxacin as third-line eradication treatment of Helicobacter pylori
Acronym
Helicobacter pylori rescue therapy by sitafloxacin
Scientific Title
Efficacy of sitafloxacin as third-line eradication treatment of Helicobacter pylori
Scientific Title:Acronym
Helicobacter pylori rescue therapy by sitafloxacin
Region
| Japan |
Condition
Condition
H. pylori infection
Classification by specialty
| Gastroenterology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy of sitafloxacin as third-line eradication treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Eradication rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eradication treatment by rabeprazole 10mg q.i.d. and amoxicillin 500mg q.i.d. and sitafloxacin 100mg b.i.d. for 7 days
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
H. pylori positive patient after first-line and second-line eradication treatment
Key exclusion criteria
1. Patient with severe heart failure, renal failure or infection.
2. Patients with allergy for rabeprazole, amoxicillin or sitafloxacin.
3. Pregnant patient.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
Organization
National Organization Tokyo medical center
Division name
Gastroenterology
Zip code
Address
2-5-1higashigaoka Meguro-ku Tokyo
TEL
03-3411-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nishizawa |
Organization
National Organization Tokyo medical center
Division name
Gastroenterology
Zip code
Address
TEL
03-3411-0111
Homepage URL
Sponsor or person
Institute
National Organization Tokyo medical center
Institute
Department
Personal name
Funding Source
Organization
National Organization Tokyo medical center
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 04 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 22 | Day |
Last modified on
| 2014 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005689
