UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013780 |
|---|---|
| Receipt number | R000016083 |
| Scientific Title | Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older |
| Date of disclosure of the study information | 2014/04/28 |
| Last modified on | 2017/09/08 16:09:06 |
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Basic information
Public title
Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older
Acronym
Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older
Scientific Title
Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older
Scientific Title:Acronym
Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We confirm blood kinetics of the hyaluronic acid after the ECM-E (hyaluronic acid made from a cockscomb) intake.
After ECM-E intake, a blood level of the hyaluronic acid is measured in 0, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 8.0 hours later.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
We confirm blood kinetics of the hyaluronic acid after the ECM-E (hyaluronic acid made from a cockscomb) intake.
After ECM-E intake, a blood level of the hyaluronic acid is measured in 0, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 8.0 hours later.
Key secondary outcomes
We confirm the safety and the amount of change blood test general, biochemistry, urinalysis.
After ECM-E intake, we give test mentioned above 0, 8 hours later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Food |
Interventions/Control_1
ECM-E
Intake:3000mg
Ingestion period:1day
Interventions/Control_2
ECM-E
Intake:1200mg
Ingestion period:1day
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects of the experiment and the Japanese who meet the criteria for all of the following.
1) A person who is Japanese is between 40 and 65 years old at the time of Informed Consent.
2)A person who are blood pressure and body temperature are the following at this clinical trial and the screening. Blood pressure :
Systolic 140mmHg less than
Diastolic 90mmHg less than
Body temperature:35.5-37.0degrees
3)A person who is in the range of more than 15ng/mL and less than 50ng/mL in blood hyaluronic acid concentration.
4) A person who received a full explanation about the expected objectives of the test food and the clinical test and the side effects at the screening from clinical research investigator (or subinvestigators), and agreed on the application with written informed consent for this clinical trial spontaneously upon well understanding.
5) The person who can discontinue smoking on the clinical trials day
6) A person who can comply with the management issues in the implementation medical institutions.
7) The person who was qualified by principal investigator or sub investigator in the screening test within 60 days of this clinical trials implementation.
Key exclusion criteria
The subjects in conflict with any of the following condition are excluded.
1) A person who is liver dysfunction is suspected in clinical laboratory values are as follows screening.
a) T-Bil 3.0 or more
b) GOT, GPT upper limit of normal multiply 2.5 or more (100)
c) Al-P upper limit of normal multiply 2.5 or more
d) gamma-GTP upper limit of normal multiply 1.5 or more
e) LDH upper limit of normal multiply 1.5 or more
2) A person who with the disease to gastrointestinal tract, liver, kidney, the heart which have an influence on absorption, distribution, metabolism, the excretion.
3) A person with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on.
4) A person who has a food allergy in chicken and a chicken egg or a chronic food allergy.
5) A person who has Mucopolysaccharidosis.
6) Person with alcohol or drug dependence.
7) A person who has participated in other clinical study or received medical treatment of new drug within 3 months at the time of obtaining informed consent.
8) The person who took other drugs for less than one week to start this clinical trial.
9) A person who has taken the whole blood bleeds or apheresis(plasma apheresis and platelet apheresis) more than 200mL within 3 months at the time of obtaining informed consent or during the period between the time of obtaining informed consent and this clinical trial implementation.
10) A person who can not keep the compliance rules of participation in clinical trials and report symptoms.
11) In addition, the person who identified as improper by the principal investigator or subinvestigators.
12) A women who is pregnant or breastfeeding.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiro Kure |
Organization
Sanbongi Clinic
Division name
Clinic Director
Zip code
Address
2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL
0561-56-4532
shigehiro_kure@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Hayashi |
Organization
Medical Fusion Co.,Ltd.
Division name
Clinical Development Division
Zip code
Address
Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
TEL
052-745-3300
Homepage URL
info@m-fusion.co.jp
Sponsor or person
Institute
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
ADAPTGEN PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1,Medical institutions conduct clinical research
MEDOC Medical Dock&Clinic
2,CRO
Medical Fusion Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JMA-IIA00177
Org. issuing International ID_1
JMACCT Clinical Trials Registry
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人メドック健康クリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 21 | Day |
Last modified on
| 2017 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016083
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