UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025252 |
|---|---|
| Receipt number | R000028821 |
| Scientific Title | Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2018/06/15 13:36:32 |
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Basic information
Public title
Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Acronym
Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Scientific Title
Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Scientific Title:Acronym
Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Region
| Japan |
Condition
Condition
chronic gastritis with H.Pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the eradication rate of P-CAB-based triple therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the antimicrobial susceptibility test and eradication rate after 8weeks
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
P-cab 20mg bid + MNZ 250mg bid + STFX 100mg bid x 7days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
2nd-line eradication failure or penicillin allergy
Key exclusion criteria
< 20 years old
Patients with severe heart desease, renal dysfunction or liver dysfunction
Patients with allergy for 3rd-eradication drugs
Patients using anti-coagulation or anti-platelet drugs
Pregnants or patient who want pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Mizuta |
Organization
Kochi medical school
Division name
Department of gastroenterology and hepatology
Zip code
Address
Kohasu, Okou-town, Nankoku-city
TEL
088-880-2333
mizutahi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Mizuta |
Organization
Kochi medical school
Division name
Department of gastroenterology and hepatology
Zip code
Address
Kohasu, Okou-town, Nankoku-city
TEL
088-880-2333
Homepage URL
mizutahi@kochi-u.ac.jp
Sponsor or person
Institute
Kochi medical school
Institute
Department
Personal name
Funding Source
Organization
Kochi medical school
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028821
