UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Potassium-competitive acid blocker-based third-line triple therapy in Helicobacter Pylori eradication
Title of the study (Brief title)	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	Hiroshi Mizuta
Organization	Kochi medical school
Division name	Department of gastroenterology and hepatology
Address	Kohasu, Okou-town, Nankoku-city
TEL	088-880-2333
Email	mizutahi@kochi-u.ac.jp

Public contact
Name of contact person	Hiroshi Mizuta
Organization	Kochi medical school
Division name	Department of gastroenterology and hepatology
Address	Kohasu, Okou-town, Nankoku-city
TEL	088-880-2333
Homepage URL
Email	mizutahi@kochi-u.ac.jp

Sponsor
Institute	Kochi medical school
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028821