A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phaseII Study to Investigate the Efficacy and Safety of YYC301 in Subject With Knee Osteoarthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
261
Dong-A University Hospital.
Busan, South Korea
Bundang Seoul University Hospital
Seoul, South Korea
Gachon University Gil Medical Center
Seoul, South Korea
Gangnam Severance Hospital
100mm Pain VAS
Subjects who have severe pain at one-or both sided knee osteoarthritis directly assess the degree of pain (within 24 hours) with a straight line which has 0mm to 100mm. 0 mm means 'doesn't have pain' and 100 mm means 'maximum pain who can imagine'.In order to investigate the degree of subject's pain change from administration of YYC301(Experimental drug).
Time frame: at 1,4,8,12 weeks after randomization after administration of YYC301(Experimental drug).
KOOS(Knee Injury and Osteoarthritis Outcome Score)
KOOS survey is consisted of total 42 questions at 5 groups. 7 questions about symptoms, 9 questions about pain, 17 questions about Function in daily,5 questions about function in sport and recreation(sport/Rec), 4 questions about the knee related quality of life(QoL). Subjects who are participated in this clinical trial, they directly assess these survey with 5 point Likert scale(0\~4, 0 means 'nothing' and 4 means 'most severe') and KOOS results are converted to WOMAC score.
Time frame: at 4,8,12 weeks after randomization after administration of YYC301(Experimental drug).
Patient Global Assessment(PGA)
Subjects who have been admistrated YYC301 have to directly perform the patient global assessment with 5 point Likert Scale. It has 0 to 5 scales. 0 means 'very poor' and 5 means' very good' In order to investigate the Patient Global point assessment at specific weeks.
Time frame: at 4,8,12 weeks after randomization after administration of YYC301(Experimental drug).
Total dosage and dosage rate of rescue treatment.
Subjects who administration of YYC301(Experimental drug) are investigated total dosage and dosage rate of rescue treatment.
Time frame: at screening time(visit 1; 2 weeks before next visit 2), randomization(visit 2), 4, 8 weeks after randomization.
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experimental medication
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
KyungHee University Medical Center
Seoul, South Korea
Soonchungyand University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital.
Seoul, South Korea