UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of acid inhibition without hypergastrinemia
Title of the study (Brief title)	Development of acid inhibition
Region	Japan

Condition
Condition	Hypergastrinemia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of safety and effective acid inhibition therapy without hypergastrinemia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intragastric pH
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	VPZ 10mg/day
Interventions/Control_2	LAF 10mg x 2/day
Interventions/Control_3	PIR 25mg x 3/day
Interventions/Control_4	VPZ 10mg/day plus LAF 10mg x 2/day
Interventions/Control_5	VPZ 10mg/day plus PIR 25mg x 3/day
Interventions/Control_6	VPZ 10mg/day plus LAF 10mg x 2/day plus PIR 25mg x 3/day
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	The H.pylori naive candidate without medication in recent one month
Key exclusion criteria	1.The candidate with past history 2.The candidate with pregnancy or breast-feeding 3.Smoker 4.The candidate without allowance of Medical Docter
Target sample size	40

Research contact person
Name of lead principal investigator	Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2261
Email	furuta@hama-med.ac.jp

Public contact
Name of contact person	Takahiro Suzuki
Organization	Hamamatsu University School of Medicine
Division name	First Department of Medicine
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2261
Homepage URL
Email	takahr99@hama-med.ac.jp

Sponsor
Institute	First Department of Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 04 Month 01 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	2018 Year 03 Month 07 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036111