UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019000 |
|---|---|
| Receipt number | R000021978 |
| Scientific Title | Helicobacter pylori eradication therapy with Vonoprazan-amoxicillin-clarithromycin triple therapy - effect on Helicobacter pylori clarithromycin resistance - |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2020/09/23 09:22:36 |
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Basic information
Public title
Helicobacter pylori eradication therapy with Vonoprazan-amoxicillin-clarithromycin triple therapy
- effect on Helicobacter pylori clarithromycin resistance -
Acronym
P-CABstusy
Scientific Title
Helicobacter pylori eradication therapy with Vonoprazan-amoxicillin-clarithromycin triple therapy
- effect on Helicobacter pylori clarithromycin resistance -
Scientific Title:Acronym
P-CABstusy
Region
| Japan |
Condition
Condition
Helicobacter pylori gastritis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effecto of triple therapy(Vonoprazan ,Amoxicillin and Clarithromycin) for resistance of Helicobacter pylori to Clarithromycin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
triple therapy of eradication rate point we want to calculate the estimated value and the 95% confidence interval.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
As eradication of H.pylori vonoprazan20mg,amoxicillin750mg and clarithromycin200mg of three drugs at tha same time twice a day for 7days to oral administration
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
1)Subject consent was obtained by sentence
2)20 years old or more of the subject
3)Subject to the upper gastrointestinal tract diseases such as gastritis and peptic ulcer is suspected
Key exclusion criteria
1)not subject to upper endoscopy
2)eradication of H.pylori in the past
3)Subjects that have been administered antibiotics to be used as a systemic administration such as orally or by injection within 28 days
4)Subjects who are taking anticoagulants
5)Subjects that are oral anti-platelet agent 2 agent or more
6)Subjects having an upper gastrointestinal tract disease requiring treatment with proton pump inhibitors
7)Subjects with a merger or history of gastric acid hypersecretory disease (Zollinger-Ellison syndrome, etc.)
8) with a history of hypersensitivity to components of the drug to be used in the present study subjects
9) subject suspected of esophageal cancer or stomach cancer
10) subjects with a history of gastrectomy or vagotomy
11)pregnant or lactating subject
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyama jyunichi |
Organization
National Center for Global Health and Medicine.
Division name
Gastroenterological medicine
Zip code
Address
1-21-1 toyama,shinjyuku,tokyo
TEL
03-3202-7181
jakiyama.ncgm@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Okubo hidetaka |
Organization
National Center for Global Health and Medicine.
Division name
Gastroenterological medicine
Zip code
Address
1-21-1 toyama,shinjyuku,tokyo
TEL
03-3202-7181
Homepage URL
h.okubo.john@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine.
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | Year | 09 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021978
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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