UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015666 |
|---|---|
| Receipt number | R000018208 |
| Scientific Title | A phase II study on periarticular injection of Anti-cytokine therapy Magnetic for the treatment of osteoarthritic knee pain. |
| Date of disclosure of the study information | 2014/11/11 |
| Last modified on | 2014/11/11 20:42:29 |
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Basic information
Public title
A phase II study on periarticular injection of Anti-cytokine therapy Magnetic for the treatment of osteoarthritic knee pain.
Acronym
Anti-Cytokine therapy for knee pain (ACTKP)
Scientific Title
A phase II study on periarticular injection of Anti-cytokine therapy Magnetic for the treatment of osteoarthritic knee pain.
Scientific Title:Acronym
Anti-Cytokine therapy for knee pain (ACTKP)
Region
| Japan |
Condition
Condition
Patients with knee pain due to osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this work is to reserch the efficacy of anti-TNF-alpha and injecting and anti-IL6 directly into the joint for the treatment of osteoarthritic knee pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain relief
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
knee injection of anti-TNFalfa inhibitors
Interventions/Control_2
knee injection of IL6 inhibitors
Interventions/Control_3
knee injection of Hyaluronic acid
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients have a knee joint pain and the cause of pain could be explained pain in X-ray or MRI
Key exclusion criteria
1 Patients with impaired consciousness
2 Patients with severe heart failure, renal failure, liver failure, and systemic complications such as respiratory failure
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate School of Medicine, Chiba University
Division name
Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan.
TEL
043-226-2117
sohotri@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Ohtori |
Organization
Graduate School of Medicine, Chiba University
Division name
Orthopaedic Surgery
Zip code
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan.
TEL
043-226-2117
Homepage URL
http://www.chiba-orthopaedics.com/top.html
sohotri@faculty.chiba-u.jp
Sponsor or person
Institute
Dept. of Orthopaedic Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Eisai grant(2012)
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
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
| 2014 | Year | 11 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 11 | 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
| 2014 | Year | 11 | Month | 11 | Day |
Last modified on
| 2014 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018208
