UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005643 |
|---|---|
| Receipt number | R000006666 |
| Scientific Title | Effects of COX-2 selective inhibitor and hyaluronan acid to prevent cartilage degeneration in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/05/25 19:04:14 |
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Basic information
Public title
Effects of COX-2 selective inhibitor and hyaluronan acid to prevent cartilage degeneration in patients with knee osteoarthritis
Acronym
Effects of COX-2 selective inhibitor and hyaluronan acid to prevent cartilage degeneration
Scientific Title
Effects of COX-2 selective inhibitor and hyaluronan acid to prevent cartilage degeneration in patients with knee osteoarthritis
Scientific Title:Acronym
Effects of COX-2 selective inhibitor and hyaluronan acid to prevent cartilage degeneration
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this research study is to quantitatively and objectively evaluate the efficacy of oral administration of COX-2 selective inhibitor and intraarticular injection of hyaluronan acid to halt or reverse the progression of cartilage degeneration in patients with osteoarthritis using T2 mapping.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI examination with T2 mapping
Key secondary outcomes
1) MRI examination with Modified Outerbridge classification (T1 weighted image, T2 weighted image, etc.), 2) simple X-ray examination with Kellgren-Lawrence classification, 3) assessment of clinical symptoms using JKOM (Japanese Knee Osteoarthritis Measure), Lysholm score, and VAS (visual analogue scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)COX-2 selective inhibitor group (36 cases)
A fixed daily dose of COX-2 selective inhibitor, celecoxib (200mg/day in 2 divided doses) will be administered orally for 3 months.
Interventions/Control_2
2)Hyaluronan acid group (36 cases)
A fixed dose of sodium hyaluronate injection (25mg/day, once) will be administered intraarticularly once a week for 4 weeks. After 4 weekly injections, a total of 4 injections will be given every 2 weeks (8 injections in total in approximately 3 months).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Of knee osteoarthritis patients treated at the Chiba Medical Center on an outpatient basis, those who satisfy all the following inclusion criteria and do not meet any of the following exclusion criteria will be selected. A total of 72 subjects will be enrolled.
1) Diagnosed as knee osteoarthritis with Kellgren & Lawrence grade of I to III by simple X-ray imaging of knee joint in the upright and frontal position at the first visit
2) Written informed consent
3) Age: 20 years and <75 years
4) Exercise pain or rest pain for more than 3 months
Key exclusion criteria
Patients who meet any of the following exclusion criteria will not be enrolled in this research study.
1) History of hypersensitivity to any components of the investigational products to be used in this research study
2) History of hypersensitivity to any other medicinal products
3) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
4) Secondary knee osteoarthritis due to trauma or other diseases
5) History of surgery of the involved knee joint (including arthroscopy)
6) Conservative therapy of the involved knee joint within one month of enrollment in this study
7) Diseases in the involved knee joint other than those associated with osteoarthritis, e.g., injury of semi-lunar disc, ligament injury, and cartilage injury
8) Serious renal, hepatic, and/or cardiovascular disease
9) Significant mental disorder, drug dependence, and/or alcohol abuse
10) Patients who are unable to come to the medical center for all scheduled visits
11) Other patients considered to be ineligible for this research study by the investigator
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuya Watanabe |
Organization
Teikyo University Chiba Medical Center
Division name
Orthopaedic Surgery
Zip code
Address
3426-3 Anesaki, Ichihara, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Teikyo University Chiba Medical Center
Division name
Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Teikyo University Chiba Medical Center
Institute
Department
Personal name
Funding Source
Organization
Teikyo University Chiba Medical Center
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
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
| 2011 | Year | 06 | Month | 01 | 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
| 2009 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | 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
| 2011 | Year | 05 | Month | 25 | Day |
Last modified on
| 2011 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006666
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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