UMIN-CTR Clinical Trial

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
Email	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
Email	h.okubo.john@gmail.com

Sponsor
Institute	National Center for Global Health and Medicine.
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021978