UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013594 |
|---|---|
| Receipt number | R000015881 |
| Scientific Title | Establishment of treatment regimen to eradicate H. pylori infection in patients who failed 1st-line and 2nd-line therapy. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2020/04/06 13:41:40 |
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Basic information
Public title
Establishment of treatment regimen to eradicate H. pylori infection in patients who failed 1st-line and 2nd-line therapy.
Acronym
Alternative eradicate therapy for H. pylori infection.
Scientific Title
Establishment of treatment regimen to eradicate H. pylori infection in patients who failed 1st-line and 2nd-line therapy.
Scientific Title:Acronym
Alternative eradicate therapy for H. pylori infection.
Region
| Japan |
Condition
Condition
Helicobacter pylori-associated gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish a treatment regimen to eradicate H. pylori infection in patients who failed conventional therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
eradication rate
Key secondary outcomes
side effects
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
Treat the patients who failed conventinal eradication therapy using sitafloxasin containing regimen
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who was diagnosed as infected-with H. pylori
Key exclusion criteria
who did not agree
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinsaku |
| Middle name | |
| Last name | Fukuda |
Organization
Hirosaki University Graduate School of Medicine
Division name
Gastroenterology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki
TEL
0172-39-5053
tsimo_hki@hotmail.com
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Shimoyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Gastroenterology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki
TEL
0172-39-5053
Homepage URL
tsimo@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki 06-8562, Japan
Tel
0172-39-5053
tsimo@hirosaki-u.ac.jp
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
弘前大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/journal/15235378
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/journal/15235378
Number of participants that the trial has enrolled
50
Results
The eradication rate of PCAB-AMOX-STFX was 85.7% (42/49; 95% CI, 75.9-95.5%) by intention-to-treat analysis and 87.5% (42/48; 78.4-96.9%) by per protocol analysis. Eradication was unsuccessful in one of two patients whose strains had low sensitivity to AMOX and three patients whose strains were resistant to STFX In contrast, eradication therapy was successful in 13 patients infected with strains which were sensitive to both AMOX and STFX.
Results date posted
| 2020 | Year | 04 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
not accepted.
Date of the first journal publication of results
Baseline Characteristics
H. pylori-positive patients who had failed both first-line therapy (PPI or VPZ + AMOX + clarithromycin) and second-line therapy (PPI or VPZ + AMOX + metronidazole) were enrolled into the study.
Participant flow
Prior to the third-line therapy, patients underwent endoscopy to obtain H. pylori strains to test the susceptibility to antibiotics if they agreed.
Adverse events
None.
Outcome measures
The eradication rate of PCAB-AMOX-STFX was 85.7% (42/49; 95% CI, 75.9-95.5%) by intention-to-treat analysis and 87.5% (42/48; 78.4-96.9%) by per protocol analysis. H. pylori was isolated from 19 patients before starting the triple therapy of PCAB, AMOX and STFX. Eradication was unsuccessful in one of two patients whose strains had low sensitivity to AMOX. In contrast, eradication therapy was successful in 13 patients infected with strains which were sensitive to both AMOX and STFX.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015881
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