UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051730 |
|---|---|
| Receipt number | R000059030 |
| Scientific Title | Observation of knee joints in adult with knee discomfort |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2023/09/15 09:49:01 |
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Basic information
Public title
Observation of knee joints in adult with knee discomfort
Acronym
Observation of knee joints in adult with knee discomfort
Scientific Title
Observation of knee joints in adult with knee discomfort
Scientific Title:Acronym
Observation of knee joints in adult with knee discomfort
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of MRI imaging methods for the knee
Basic objectives2
Others
Basic objectives -Others
Comparison of first and second MRI imaging of the knee joint
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of first and second MRI imaging of the knee joint
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects with the knee joint discomfort.
2) Subjects with a BMI of less than 30kg/m^2.
Key exclusion criteria
1) Subjects with severe pain in joints other than the knee joint.
2) Subjects who have a current or previous history of joint disease or serious disease that affects efficacy evaluation.
3) Subjects who regularly use medicines and health foods that affect efficacy evaluation.
4) Subjects who are judged inappropriate by the investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Tanaka |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-3452-9559
ko.tanaka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Tsujikami |
Organization
KOBAYASHI Pharmaceutical Co.,Ltd
Division name
Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa, Ibaraki-city, Osaka
TEL
080-3851-9772
Homepage URL
m.tsujikami@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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.jp
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 | 07 | 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
| 2023 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observational
Management information
Registered date
| 2023 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059030
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
