UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022989
Receipt number R000007606
Scientific Title Comparative study of once vs. twice daily regimen of double dose of rabeprazole in uncontrolled GERD patients taking usual dose of proton pump inhibitors.
Date of disclosure of the study information 2016/07/02
Last modified on 2017/01/04 09:36:59

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Basic information

Public title

Comparative study of once vs. twice daily regimen of double dose of
rabeprazole in uncontrolled GERD patients taking usual dose of proton pump
inhibitors.

Acronym

Once vs. twice daily regimen of double dose PPI in GERD

Scientific Title

Comparative study of once vs. twice daily regimen of double dose of
rabeprazole in uncontrolled GERD patients taking usual dose of proton pump
inhibitors.

Scientific Title:Acronym

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

1st name
Middle name
Last name Akira Mizuki

Organization

Keiyu Hospital

Division name

Internal medicine

Zip code


Address

3-7-3 Minatomirai,Nishi-ku,Yokohama

TEL

045-221-8181

Email

a-mizuki@keiyu-hospital.com


Public contact

Name of contact person

1st name
Middle name
Last name Akira Mizuki

Organization

Keiyu Hospital

Division name

Internal medicine

Zip code


Address

3-7-3 Minatomirai,Nishi-ku,Yokohama

TEL

045-221-8181

Homepage URL


Email

a-mizuki@keiyu-hospital.com


Sponsor or person

Institute

Keiyu Hospital
Internal Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 09 Month 13 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007606


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name