The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose.
This is a dose-response, double blind , placebo-controlled study. All patients are required to have 2 weeks washout period from prior medication. Subjects will discontinue current medications 2 weeks prior to randomization. Among those who meet the inclusion criteria, only subjects recording visual analogue scale(VAS) of higher than 40mm(VAS range from 0mm(no pain) to 100mm(unbearable pain)) are enrolled in this study. Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
identical number of tablets to active drug groups
KyungHee University medical center
Seoul, Hoegi-dong, Dongdaemun-gu, South Korea
RECRUITINGAjou University Medical Center
Gyeonggi-do, Woncheon-dong Yeongtong-gu, Suwon, South Korea
RECRUITINGSeoul National University Hospital
Seoul, Yongon-dong, Chongno-gu, South Korea
RECRUITINGK-WOMAC
The primary endpoint will be the change in the sum of the K-WOMAC OA index at Visit 6(8 weeks) vs. baseline(Visit 2, 0 week).
Time frame: Visit 6(8 week), baseline
knee pain intensity assessment
The change from baseline to each day(4 week and 8 week). Subjects assess knee pain intensity by using 100mm VAS at each time.
Time frame: baseline, Visit 4(4 week), Visit 6(8 week)
Global assessment(regarding to disease activity)
The change from Visit 4 to Visit 6 using 100mm VAS. Each patient and investigator assess by using 100mm VAS.
Time frame: Visit 4(4 week), Visit 6(8 week)
K-WOMAC each domain assessment
The change from Visit 6(8 weeks) vs. baseline(Visit 2, 0 week) in the K-WOMAC each domain score. \* K-WOMAC 3 domains: pain domain, stiffness domain, physical function domain
Time frame: baseline, Visit 6(8 week)
ESR & hs-CRP
The change from baseline to each day(Visit 4, Visit 6) using laboratory test.
Time frame: baseline, Visit 4(4 week), Visit 6(8 week)
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