UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled study to examine the effects of a triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients.
Title of the study (Brief title)	A triple therapy with vonoprazan or rabeprazole against standard triple therapy-failed patients
Region	Japan

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

Objectives
Narrative objectives1	Comparison between a triple therapy with vonoprazan and a triple therapy with rabeprazole against standard triple therapy-failed patients, and investigation of their adverse effects.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison on an eradication rate between a triple therapy with vonoprazan and a triple therapy with rabeprazole
Key secondary outcomes	Comparison of adverse effects between a triple therapy with vonoprazan and a triple therapy with rabeprazole

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	vonoprazan, metronidazole, amoxicillin
Interventions/Control_2	rabeprazole, metronidazole, amoxicillin
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 failed standard triple therapy
Key exclusion criteria	1. Patients who cannot cancel a proton pump inhibitor for 2 weeks before judgment after re-eradication therapy. 2. Patients who have past history of drug allergy. 3. Patients who have severe diseases affecting the kidney, the heart, and the liver. 4. Patients who are pregnant, who may be pregnant, or who are nursing.
Target sample size	70

Research contact person
Name of lead principal investigator	Mariko Hojo
Organization	Juntendo University School of Medicine
Division name	Department of Gastroenterology
Address	2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL	03-3813-3111
Email	mhojo@juntendo.ac.jp

Public contact
Name of contact person	Mariko Hojo
Organization	Juntendo University School of Medicine
Division name	Department of Gastroenterology
Address	2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL	03-3813-3111
Homepage URL
Email	mhojo@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine, Department of Gstroenterology
Institute
Department

Funding Source
Organization	Juntendo University School of Medicine, Department of Gstroenterology
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	順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 20 Day
Anticipated trial start date	2015 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	2015 Year 02 Month 22 Day
Last modified on	2018 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019265