UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013780
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email info@m-fusion.co.jp

Sponsor
Institute ADAPTGEN PHARMACEUTICAL CO.,LTD.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.