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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034291
Receipt No. R000038845
Scientific Title Comparison of the tear level between (-)-epigallocatechin gallate (EGCG) and (-)-epigallocatechin 3-O-(3-O-methyl) gallate (EGCG3"Me) after oral administration in healthy volunteers.
Date of disclosure of the study information 2019/03/31
Last modified on 2019/01/04

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Basic information
Public title Comparison of the tear level between (-)-epigallocatechin gallate (EGCG) and (-)-epigallocatechin 3-O-(3-O-methyl) gallate (EGCG3"Me) after oral administration in healthy volunteers.
Acronym Comparison of the tear level in green tea catechins after oral administration in healthy volunteers.
Scientific Title Comparison of the tear level between (-)-epigallocatechin gallate (EGCG) and (-)-epigallocatechin 3-O-(3-O-methyl) gallate (EGCG3"Me) after oral administration in healthy volunteers.
Scientific Title:Acronym Comparison of the tear level in green tea catechins after oral administration in healthy volunteers.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Hematology and clinical oncology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Mesurement of the tear level in green tea catechins (EGCG, EGCG3"Me) after oral administration in healthy volunteer.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The tear level of pharmacokinetic parameter (AUC 0-24, Cmax) of EGCG and EGCG3Me after green tea administration.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 For the EGCG-containing tea treatment or EGCG3Me-containing tea treatment
Interventions/Control_2
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
45 years-old >
Gender Male and Female
Key inclusion criteria Japanese healthy adults
Key exclusion criteria When an adverse event develops (including the accident).
When we judge that a study responsibility physician or a study allotment physician should discontinue it.
When a study is stopped on account of the subjects (moving, the pressure).
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Udaka
Organization Showa University
Division name Department of Pharmacology, School of Medicine
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8125
Email ykanda@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Hida
Organization ShowaUnivrsity
Division name Department of Pharmacology Clinical Pharmacology
Zip code
Address 6-11-11 Kitakarasuyama Setagaya-ku
TEL 03-3300-5254
Homepage URL
Email n.hidada@med.showa-u.ac.jp

Sponsor
Institute Department of Pharmacology Clinical Pharmacology, School of Medicine, Showa University, Clinical Research Institute for Clinical Pharmacology and Therapeutics
Institute
Department

Funding Source
Organization Promotion and Mutual Aid Corporation for Private Schools of Japan
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
2019 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 15 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 27 Day
Last modified on
2019 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=R000038845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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