UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006483 |
|---|---|
| Receipt number | R000007693 |
| Scientific Title | Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between sitafloxacin-including regimen and sitafloxacin and metronidazole-including regimen |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2016/01/21 19:58:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between sitafloxacin-including regimen and sitafloxacin and metronidazole-including regimen
Acronym
Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy
Scientific Title
Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between sitafloxacin-including regimen and sitafloxacin and metronidazole-including regimen
Scientific Title:Acronym
Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy
Region
| Japan |
Condition
Condition
H. pylori-positve patients after the 2nd line eradication failure
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of H. pylori eradication rates for 10 days between regimen with STFX, AMPC and PPI and regimen with STFX, MNZ and PPI.
Basic objectives2
Others
Basic objectives -Others
The pre-eradication MIC of STFX, AMPC, MNZ
The gyrA mutation
The FIC index of the interation for STFX and MNZ
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The efficacy of H. pylori eradication
Key secondary outcomes
MIC of STFX, FIC index of the interaction between STFX and MNZ, gyaA mutation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
esomeprazole 40mg, q.i.d., amoxicillin 2.0g, q.i.d., sitafloxacin 200 mg, b.i.d.
Interventions/Control_2
esomeprazole 40mg, q.i.d., metronidazole 500mg, q.i.d., sitafloxacin 200 mg, b.i.d.
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
H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent
Key exclusion criteria
1. Patients with allergy for quinolones
2. Patients with allergy for PPIs
3. Patients with severe liver injury and/or severe renal damage
4. Pregnancy or possible pregnancy
5. Patients who were recognized as inappropriate for entry
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3914
hsuzuki@a6.keio.jp
Public contact
Name of contact person
| 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
070-6946-1119
Homepage URL
http://web.sc.itc.keio.ac.jp/medicine/PYLORI/small/index.html
hsuzuki@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | 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
| 2011 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007693
