UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis.
Title of the study (Brief title)	A randomized controlled trial comparing the first-line eradication rate using vonoprazan or PPI for Helicobacter pylori infectious gastritis.
Region	Japan

Condition
Condition	Helicobacter pylori infectious gastritis.
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We comparing first-line eradication rate VPZ therapy (VPZ group) with PPI therapy (PPI group) for the treatment of H.pylori infectious gastritis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eradication rates and adverse events. We evaluate the eradication in all cases using C13-urea breath test (UBT) at eight weeks after completion of the therapy. We perform a questionnaire to a patient, and we evaluate presence of a diarrhea, loose stool, exanthem, taste disorder, fever, other physical condition defectiveness about the side effect.
Key secondary outcomes	Taking medicine compliance.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We give vonoprazan 20mg and amoxicillin 750mg and clarithromycin 200mg or 400mg twice daily for 7 days.
Interventions/Control_2	We give rabeprazole 20mg and amoxicillin 750mg and clarithromycin 200mg or 400mg of the pack preparation twice a day for 7 days or lansoprazole 30mg and amoxicillin 750mg and clarithromycin 200mg or 400mg that of pack preparation twice a day for 7 days.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	H.pylori infectious gastritis.
Key exclusion criteria	80 years old or older. A patient has severe organ dysfunction. A patient having allergy of the study drug. A patient that it was judged that eradication was inappropriate on the medical examination of the medical attendant.
Target sample size	200

Research contact person
Name of lead principal investigator	masafumi maruyama
Organization	nagano red cross hospital
Division name	gastroenterology
Address	5-22-1, wakasato, nagano, nagano
TEL	026-226-4131
Email	m.maruyama@nagano-med.jrc.or.jp

Public contact
Name of contact person	masafumi maruyama
Organization	nagano red cross hospital
Division name	gastroenterology
Address	5-22-1, wakasato, nagano, nagano
TEL	026-226-4131
Homepage URL
Email	m.maruyama@nagano-med.jrc.or.jp

Sponsor
Institute	nagano red cross hospital
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)

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 02 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 23 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024299