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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
