UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035774 |
|---|---|
| Receipt number | R000040749 |
| Scientific Title | Noncoding RNA related to pain of osteoarthritis: Does miR-21 relate to osteoarthritic pain? |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2021/02/05 11:02:56 |
* 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
Noncoding RNA related to pain of osteoarthritis: Does miR-21 relate to osteoarthritic pain?
Acronym
Involvement of miR-21 in osteoarthritic pain
Scientific Title
Noncoding RNA related to pain of osteoarthritis: Does miR-21 relate to osteoarthritic pain?
Scientific Title:Acronym
Involvement of miR-21 in osteoarthritic pain
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose is development of a new therapeutic agent of osteoarthritis (OA) by identification of noncoding RNA related to OA pain.
Basic objectives2
Others
Basic objectives -Others
Mechanisms of disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of miR-21 expression in synovium and synovial fluid of OA patients and Knee Injury and Osteoarthritis Outcome Score(KOOS) Pain Score
Key secondary outcomes
(1) Correlation of miR-21 expression in synovium and synovial fluid of OA patients and Pain VAS score
(2) miR-21 expression of each group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the department of orthopaedic surgery of Nippon Medical School are considered for trial recruitment.
Eligibility criteria also includes an age of at least 20 years and any of following criteria.
(1) Patients with Kellgren-Lawrence classifications III-IV knee OA who take arthrocentesis of knee in outpatient clinic and whose pain VAS score is less than 50mm
(2) Patients without knee OA who take arthroscopic surgery and whose pain VAS score is less than 50mm
(3) Patients with knee OA who take knee replacement
Key exclusion criteria
(1) Patients who do not consent for this research
(2) Patients who have psychiatric disorder
(3) Patients who can not answer questionnaire for pain due to dementia and others
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Hoshikawa |
Organization
Nippon Medical School
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL
+81-3-3822-2131
hoshikawa-nms@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Hoshikawa |
Organization
Nippon Medical School
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL
+81-3-3822-2131
Homepage URL
hoshikawa-nms@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 04 | 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
| 2019 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Confirmatory sudy
Patients who visit our department from February 4, 2019 to January 31, 2023 and meet the inclusion criteria are adopted.
Pain VAS score and KOOS score are recorded.
miR-21 expression in synovium and synovial fluid are measured by quantitative Polymerase Chain Reaction (PCR).
Management information
Registered date
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040749
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
