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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024567
Receipt No. R000028277
Scientific Title Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Date of disclosure of the study information 2016/11/01
Last modified on 2018/10/29

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Basic information
Public title Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Acronym Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Scientific Title Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Scientific Title:Acronym Single-dose study to examine the pharmacokinetics of the L-arginine for healthy adults
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of L-arginine for healthy adults
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes -Efficacy:
Change in walking speed as measured by 10 meter walk test from Day 0 to Day 7 (time and number of steps)
Key secondary outcomes -Safety:
Adverse event (frequency and severity)
Effect on Endocrine (To reveal the endocrine on behalf of growth hormone on Day 0,7,14,28)
Effect on metabolism (To reveal the metabolism on behalf of lactic acid, pyruvic acid and blood gas analysis on Day 0,7,14,28)
Effect on immunity (To reveal the immunity on behalf of cytokine and chemokine on Day 0,7,14,28)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Take 20g of Argi-U Granule 3-4 times a day for 7 days consecutively
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Subjects must have signed an informed consent form at age 20 or older
(2) Subjects must have voluntarily signed written informed consent to participate in the study
And also, subjects who desire to only investigate the end point without taking Argi-U Granule after understanding purpose of this study
(3) Subjects who can and plan to visit the hospital according to the study schedule
Key exclusion criteria (1) Subjects who have participated in interventional studies within 16 weeks prior to signing the patient informed consent
(2) Subjects who have history disease such as endocrine/metabolic disease, autoimmune disorder and immunodeficiency affects the secondary end point
(3) Subjects with serious complications such as heart failure, lung diseases, kidney failure, liver failure and uncontrolled diabetes
(4) Subjects with cancer or history of cancer
(5) Subjects or breast-feeding women, women suspected of being pregnant and patients who do not consent to prevent conception by taking appropriate means with the assistance of their partners during the study period
(6) Subjects considered unsuitable for participation in the study by the principal investigators or sub-investigators
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Takashima
Organization Kagoshima University Hospital
Division name Department of Neurology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan
TEL 099-275-5332
Email thiroshi@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Matsuura
Organization Kagoshima University Hospital
Division name Department of Neurology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima City, Kagoshima 890-8520, Japan
TEL 099-275-5332
Homepage URL
Email pine@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Hospital
Institute
Department

Funding Source
Organization The Research on Measures for Intractable Diseases Project of Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 鹿児島大学病院(鹿児島)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 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 10 Month 26 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028277

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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