UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of once vs. twice daily regimen of double dose of rabeprazole in uncontrolled GERD patients taking usual dose of proton pump inhibitors.
Title of the study (Brief title)	Once vs. twice daily regimen of double dose PPI in GERD
Region	Japan

Condition
Condition	Gastro-Esophageal Reflux Disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify the effectiveness of once or twice daily regimen of double dose of rabeprazole in uncontrolled GERD patients taking usual dose of proton pump inhibitors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of GERD symptoms,sleep disturbance and QOL
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Twice per day divided administration method
Interventions/Control_2	Once per day administration method
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	89 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who have received upper GI endoscopic examination during 4 weeks before the clinical trial starts .Subjects who have not received two-fold dose administration of PPI during 4 weeks before the clinical trial starts Subjects who give informed consent by written from themselves or family members
Key exclusion criteria	Subjects who have any mental disorders Subjects who have histories of allergy against laperazol Subjects who have serious complications and problems to continue to perform this clinical trial Subjects who are pregnant, possibly pregnant, or feeding her children Subjects who cannot accept an upper GI endoscopic examination Subjects who have two-fold dose of PPI during 4 weeks before the clinical trial starts Subjects who are decided to be unacceptable for this clinical trial by their clinical physicians
Target sample size	100

Research contact person
Name of lead principal investigator	Akira Mizuki
Organization	Keiyu Hospital
Division name	Internal medicine
Address	3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL	045-221-8181
Email	a-mizuki@keiyu-hospital.com

Public contact
Name of contact person	Akira Mizuki
Organization	Keiyu Hospital
Division name	Internal medicine
Address	3-7-3 Minatomirai,Nishi-ku,Yokohama
TEL	045-221-8181
Homepage URL
Email	a-mizuki@keiyu-hospital.com

Sponsor
Institute	Keiyu Hospital Internal Medicine
Institute
Department

Funding Source
Organization	Keiyu Hospital Internal Medicine
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 07 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 13 Day
Anticipated trial start date	2011 Year 10 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 02 Day
Last modified on	2017 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007606