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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name