UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of improved Helicobacter pylori eradication rate using Vonoprazan for first-line therapy: large prospective study.
Title of the study (Brief title)	H. pylori eradication rate using Vonoprazan
Region	Japan

Condition
Condition	Helicobacter pylori infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of the Helicobacter pylori eradication of first-line therapy using Vonoprazan
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eradication rate of Helicobacter pylori
Key secondary outcomes	Changes of abdominal symptom (GSRS) Risk factors for the failure of Helicobacter pylori eradication (Age, Sex, smoking habit, drinking habit, obesity, past history, medication)

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	Vonoprazan 20mg / Vonoprazan 20mg bid Amoxicillin 750mg / Amoxicillin 750mg bid Clarithromycin 400mg / Clarithromycin 400mg bid daily for 7 days
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 with Helicobacter pylori infection Willingness to provide informed consent.
Key exclusion criteria	Patients with gastric cancer identified by initial gastroduodenal endoscopy Patients who hava allergy to eraducation drugs Patients who have severe diseases affecting the kidney. Patients who have severe diseases affecting the heart. Patients who have severe diseases affecting the liver. Patients judged as inappropriate candidates for the trial by the investigators
Target sample size	500

Research contact person
Name of lead principal investigator	Yoshitsugu Misumi
Organization	NTT Medical Center Tokyo
Division name	Gastroenterology
Address	5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo,141-8625,Japan
TEL	03-3448-6547
Email	yoshikft34@gmail.com

Public contact
Name of contact person	Yoshitsugu Misumi
Organization	NTT Medical Center Tokyo
Division name	Gastroenterology
Address	5-9-22,Higashi-Gotanda,Shinagawa-Ku,Tokyo,141-8625,Japan
TEL	03-3448-6547
Homepage URL
Email	yoshikft34@gmai.com

Sponsor
Institute	NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization	NTT Medical Center Tokyo
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 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 26 Day
Anticipated trial start date	2016 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 07 Day
Last modified on	2019 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024481