UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034291 |
|---|---|
| Receipt number | 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 17:00:33 |
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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
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
n.hidada@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Pharmacology Clinical Pharmacology, School of Medicine, Showa University, Clinical Research Institute for Clinical Pharmacology and Therapeutics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038845
