UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective study in clinical course of Heicobacter pylori eradication therapy
Title of the study (Brief title)	H. pylori eradication therapy
Region	Japan

Condition
Condition	H.pylori infected patients
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims are to compare success rates in H. pylori eradication therapies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is non-inferiority of vonoprazan-based therapy for other regimens including PPI-based therapy.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who received eradication therapy(vonoprazan, PPI)
Key exclusion criteria	patient who refused the therapy
Target sample size	427

Research contact person
Name of lead principal investigator	Hiroki Tanabe
Organization	International University of Health and Welfare Hospital
Division name	Department of Gastroenterology
Address	537-3 Iguchi Nasushiobara, Tochigi
TEL	+81-287393060
Email	tant@asahikawa-med.ac.jp

Public contact
Name of contact person	Hiroki Tanabe
Organization	International University of Health and Welfare Hospital
Division name	Department of Gastroenterology
Address	537-3 Iguchi Nasushiobara, Tochigi
TEL	+81-287393060
Homepage URL
Email	tant@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Asahikawa Medical University
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 04 Month 25 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 04 Month 01 Day
Date analysis concluded	2018 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1186/s12941-018-0281-x
Results	Vonoprazan-based triple therapy was effective as susceptibility-guided triple therapy for H. pylori eradication.
Other related information	observational study

Management information
Registered date	2018 Year 04 Month 23 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036883