UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Vonoprazan for sleeping dysorder caused by gastroesophageal reflux disease (GERD) symptoms.
Title of the study (Brief title)	Efficacy of Vonoprazan for sleeping dysorder caused by GERD symptoms.
Region	Japan

Condition
Condition	gastroesophageal reflux disease (GERD)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	An investigation of the efficacy of Vonoprazan for sleeping dysorder caused by GERD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	An improvement of the sleeping dysorder caused by GERD, in 4, 8, 12 and 16 weeks after start of administration.
Key secondary outcomes

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	Administration of Vonoprazan 20mg/day for 8 weeks p.o., continued by 10mg/day for 8 weeks p.o.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	An outpatient who is diagnosed as reflux esophagitis LA grade A-D by EGD, and who has spleeping dysorder caused by GERD. No history of recent administration of PPI for 8 weeks.
Key exclusion criteria	Having oral medicine which may effect gastrointestinal motility. Equivalent to contraindications of the package insert of Vonaprazan. No history of upper gastrointestinal operation.
Target sample size	20

Research contact person
Name of lead principal investigator	Motoyoshi Izumi
Organization	Machida municipal hospital
Division name	Department of Gastroenterology
Address	2-15-41, Asahi-machi, Machida, Tokyo, Japan
TEL	042-722-2230
Email	m.izumi@machida-city-hp.jp

Public contact
Name of contact person	Motoyoshi Izumi
Organization	Machida municipal hospital
Division name	Department of Gastroenterology
Address	2-15-41, Asahi-machi, Machida, Tokyo, Japan
TEL	042-722-2230
Homepage URL
Email	m.izumi@machida-city-hp.jp

Sponsor
Institute	Machida municipal hospital
Institute
Department

Funding Source
Organization	Machida municipal hospital
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 03 Month 18 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 12 Day
Anticipated trial start date	2016 Year 04 Month 13 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 17 Day
Last modified on	2017 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024708