UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Title of the study (Brief title)	Comparison of acid inhibition attained by Vonoprazan with or without Lafutidine.
Region	Japan

Condition
Condition	Reflux esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare acid inhibitory effect of Vonoprazan and that with Lafutidine.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome is acid inhibition with the three regimens as assessed by 24-hour intragastric pH monitoring on Day7 in each regimen.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	There are three regimens as follows; (1) Vonoprazan 20mg once daily for 7 days, (2) Vonoprazan 10mg once daily for 7 days, (3) Vonoprazan 10mg and Lafutidine 10mg once daily for 7 days. Subujects receive the three different regimens in a crossover manner. The order of the four regimens is randomized as interventions 1-24. Interventions 16-24 are mentioned in other related information, because of lack of the space. A clinical research coordinator manages the dosing schedule of each subject. The washout period between the different regimens is at least 2 weeks. In each regimen, 24-h intragastric pH monitoring is performed on Day7. Interventions 1; regimen (1), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (3).
Interventions/Control_2	Interventions 2; regimen (1), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (2).
Interventions/Control_3	Interventions 3; regimen (2), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (3).
Interventions/Control_4	Interventions 4; regimen (2), washout (at least 2 weeks), regimen (3), washout (at least 2 weeks), and regimen (1).
Interventions/Control_5	Interventions 5; regimen (3), washout (at least 2 weeks), regimen (1), washout (at least 2 weeks), and regimen (2).
Interventions/Control_6	Interventions 6; regimen (3), washout (at least 2 weeks), regimen (2), washout (at least 2 weeks), and regimen (1).
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy Japanese men and women.
Key exclusion criteria	Exclusion criteria are any underlying disease, smoking habit, past or present H.pylori infection, and habitual use of any medicine.
Target sample size	30

Research contact person
Name of lead principal investigator	Takahiro Suzuki
Organization	Hamamatsu University School of Medicine
Division name	First Department of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL	053-435-2111
Email	takahr99@hama-med.ac.jp

Public contact
Name of contact person	Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL	053-435-2261
Homepage URL
Email	furuta@hama-med.ac.jp

Sponsor
Institute	First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Institute
Department

Funding Source
Organization	First Department of Medicine and Center for Clinical Research, Hamamatsu University School of Medicine, Hamamatsu, Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	浜松医科大学(静岡県)

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 12 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2017 Year 02 Month 24 Day
Date of closure to data entry	2017 Year 02 Month 24 Day
Date trial data considered complete	2017 Year 02 Month 24 Day
Date analysis concluded	2017 Year 06 Month 30 Day

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

Management information
Registered date	2016 Year 05 Month 12 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025268