UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001026 |
|---|---|
| Receipt number | R000001237 |
| Scientific Title | The effects of high molecular weight sodium hyaluronate on JKOM score and urine CTX-2 concentration -A randomized comparative clinical study with loxoprofen as a control drug- |
| Date of disclosure of the study information | 2008/02/13 |
| Last modified on | 2014/03/15 11:38:55 |
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Basic information
Public title
The effects of high molecular weight sodium hyaluronate on JKOM score and urine CTX-2 concentration -A randomized comparative clinical study with loxoprofen as a control drug-
Acronym
OA Study
Scientific Title
The effects of high molecular weight sodium hyaluronate on JKOM score and urine CTX-2 concentration -A randomized comparative clinical study with loxoprofen as a control drug-
Scientific Title:Acronym
OA Study
Region
| Japan |
Condition
Condition
Osteoarthrities
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy and safety of sodium hyaluronate on JKOM score as a primary endpoint by comparing with loxoprofen in patients with osteoarthritis of the knee.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of JKOM score from baseline.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sodium hyaluronate : Suvenyl; intra-articular injection 25mg
Interventions/Control_2
Loxoprofen : Roxonin; tablet 60mg
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
;Ambulatory outpatients with knee pain, between the ages of 50 and 80
;Regardless of gender, but in case of female, only postmenopausal patients
;Mild to moderate OA of the knee with Kellgren-Lawrence (K-L) grade of between land3
;Patients who signed informed consent documents for the treatment and investigation protocol
Key exclusion criteria
;Taken glucocorticoids (intra-articular injection, oral use, external use) within previous 4weeks
;Taken NSAIDs (oral, suppository, external) within previous 2weeks
;K-L grade of contralateral knee is 4
;Secondary OA of the knee (eg. traumatic OA of the knee)
;Patellofemoral OA (K-L grade of more than 3)
;Moderate OA other than knee
;Rheumatoid arthritis
;Having history of total knee replacement or total hip replacement
;Having history of anaphylactoid reaction to sodium hyaluronan or loxoprofene
;Peptic ulcer
;Abnormal dysemia, abnormal hepatic function, abnormal kidney function, abnormal heart function
;Aspirin-induced asthma or its history
;.Inappropriate patients from the doctor's viewpoint
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshitaka Nakamura |
Organization
University of occupational and Environmental Health
Division name
Orthopaedic Surgery.
Zip code
Address
address:1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Hayashi |
Organization
central cordinating center
Division name
Gunma univercity
Zip code
Address
Showamachi, Maebashi, Gunma 371-8514, Japan
TEL
027-220-8974
Homepage URL
knee@gunma-rct.com
Sponsor or person
Institute
Research Group of Cartilage Metabolism
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2008 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://arthritis-research.com/content/16/1/R18
Number of participants that the trial has enrolled
Results
The early efficacy of IA-HA was not inferior to that of NSAIDs, and the safety of early-phase of IA-HA was superior to that of NSAIDs for patients with knee OA.
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
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 12 | Day |
Last modified on
| 2014 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001237
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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