Unique ID issued by UMIN | UMIN000015858 |
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Receipt number | R000018453 |
Scientific Title | A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study) |
Date of disclosure of the study information | 2014/12/11 |
Last modified on | 2016/06/09 15:22:13 |
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)
A Phase II Study of SI-613 in Patients with Knee Osteoarthritis (repeat-dose study)
Japan |
Knee Osteoarthritis
Orthopedics |
Others
NO
The study objectives are to evaluate the efficacy and safety of repeated injection of SI-613 in patients with knee osteoarthritis
Efficacy
Change from baseline in following outcomes during 12 weeks
-WOMAC 3.1 Index (Pain)
-Knee pain
-50-foot walk test
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
Placebo group
SI-613 group
40 | years-old | <= |
75 | years-old | >= |
Male and Female
-Patients with a diagnosis of Knee Osteoarthritis according to ACR criteria
-Patients with radiographic evidence of Kellgren and Lawrence grade 2 or 3
-Patients with secondary OA resulting from trauma or other diseases
-Patients with risk of infection in the area of the injection site due to skin disease or infection.
160
1st name | |
Middle name | |
Last name | Yosuke Funakoshi |
SEIKAGAKU CORPORATION
Clinical Development Dept. Research & Development Div.
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan
03-5220-8593
yosuke.funakoshi@seikagaku.co.jp
1st name | |
Middle name | |
Last name | Kazuyuki Kano |
SEIKAGAKU CORPORATION
Clinical Development Dept. Research & Development Div.
6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan
03-5220-8593
kazuyuki.kano@seikagaku.co.jp
SEIKAGAKU CORPORATION
None
Self funding
NO
2014 | Year | 12 | Month | 11 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 10 | Day |
2014 | Year | 12 | Month | 11 | Day |
2014 | Year | 12 | Month | 05 | Day |
2016 | Year | 06 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018453
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