UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024875 |
|---|---|
| Receipt number | R000028464 |
| Scientific Title | The effect of proton pump inhibitor and potassium competitive acid blocker toward endothelial cells. |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2018/05/20 09:23:15 |
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Basic information
Public title
The effect of proton pump inhibitor and potassium competitive acid blocker toward endothelial cells.
Acronym
The effect of PPI and P-CAB toward endothelial cells.
Scientific Title
The effect of proton pump inhibitor and potassium competitive acid blocker toward endothelial cells.
Scientific Title:Acronym
The effect of PPI and P-CAB toward endothelial cells.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the PPI and PCAB's effect to endothelial cells.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate how PPI and PCAB effect to endothelial cells after 8week medication by measuring ADMA and FMD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Taking PPI(8weeks) before PCAB(8weeks) per os.Between them, there is 2 weeks no medication time for wash out.
Interventions/Control_2
Taking PCAB(8weeks) before PPI(8weeks) per os.Between them, there is 2 weeks no medication time for wash out.
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
AST>80 or ALT>80
Cr>1.5
No diseases
No drug addiction
No alcohol addiction
Those with written consent
Key exclusion criteria
current smoker
HbA1Cis over 6.5
BMIis over 30
Those who take other drugs.
Those who have the history of hypertension, atherosclerosis.
Those who are not allowed by research doctors.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Waranabe |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapuetics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2111
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiaki Kamiya |
Organization
Hamamatsu University School of Medicine
Division name
Department of Clinical Pharmacology and Therapuetics
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2111
Homepage URL
ilka122@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | 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 | 11 | Month | 17 | Day |
Last modified on
| 2018 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028464
