UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050010 |
|---|---|
| Receipt number | R000056921 |
| Scientific Title | The observation of knee joint for healthy adult males and females. |
| Date of disclosure of the study information | 2023/01/28 |
| Last modified on | 2025/01/12 13:23:57 |
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Basic information
Public title
The observation of knee joint for healthy adult males and females.
Acronym
The observation of knee joint for healthy adult males and females.
Scientific Title
The observation of knee joint for healthy adult males and females.
Scientific Title:Acronym
The observation of knee joint for healthy adult males and females.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The observation of the knee for healthy adult males and females.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
None
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Get two MRI scans of the knee joint per day
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult males and females
Key exclusion criteria
1. Persons who are unable to perform MRI imaging
2. Other subjects deemed unsuitable by the research institution or study site
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Matsui |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-3452-9761
y.matsui@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Mizushina |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-4063-7709
Homepage URL
y.mizushina@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
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
Shiba Palace Clinic Ethics Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2023 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
4
Results
MRI imaging of the right leg knee joint of four healthy (no knee pain) adults (2 males and 2 females) in their 30s to 50s was measured twice/day.
Accurate cartilage volume was measured without body movement during measurements.
Results date posted
| 2025 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
None
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 05 | Day |
Baseline Characteristics
Healthy adult men and women without knee pain
Participant flow
Selection was based on age and gender.
Adverse events
None
Outcome measures
Knee cartilage volume measured by MRI
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056921
