UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009058 |
|---|---|
| Receipt number | R000010439 |
| Scientific Title | The efficacy of intra-articular hyaluronic acid injections on knee osteoarthritis patients |
| Date of disclosure of the study information | 2012/10/06 |
| Last modified on | 2017/03/30 11:33:07 |
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Basic information
Public title
The efficacy of intra-articular hyaluronic acid injections on knee osteoarthritis patients
Acronym
comparative trial of HA of three kinds (CHAT study)
Scientific Title
The efficacy of intra-articular hyaluronic acid injections on knee osteoarthritis patients
Scientific Title:Acronym
comparative trial of HA of three kinds (CHAT study)
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of intra-articular treatment of knee osteoarthritis with hyaluronic acid in the knee joint is not based on randomized controlled trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
WOMAC pain, function score
Key secondary outcomes
1. Visual Analog Scale
2. EQ5D
3. KOACAD parameter on plain knee radiograph
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Synvisc:
Active Comparator
Interventions/Control_2
Suvenyl:
Active Comparator
Interventions/Control_3
Artz:
Active Comparator
Interventions/Control_4
Topical NSAIDs:
Active Comparator
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Males and females 40 to 80 years of age.
2. The ACR Criteria for osteoarthritis of the knee.
3. Radiographic evidence of OA, Kellgren and Lawrence grade 1 to 3 on prior X-rays at screening. Only the tibio-femoral joint will be evaluated.
4. Chronic pain for at least 1 month prior to study entry (WOMAC pain score)
Key exclusion criteria
1. An intra-articu1ar knee injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months.
2. A history of crystalline arthropathy or inflammatory arthritis, neutopathic arthropathy.
3. A current other problem in the affected extremity.
4. A history of clinically significant trauma or surgery.
5. Allergy or hypersensitivity to any of the study medications.
6. Joint effusion.
7. Non comp1iance to the study procedures and or non completion of the study according to investigator's judgment.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Oka |
Organization
Faculty of Medicine, the University of
Tokyo
Division name
22nd Century Medical Center
Zip code
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-5800-9545
okah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Oka |
Organization
Faculty of Medicine, University of Tokyo
Division name
22nd Century Medical Center
Zip code
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-5800-9178
Homepage URL
okah-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
TEIJIN PHARMA LIMITED.
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
| 2012 | Year | 10 | Month | 06 | 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
| 2012 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 06 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010439
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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