This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In the first 4 weeks (run-in period), the subjects will receive on-demand treatment with Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die(QD). After the run-in period, the subjects, if their knee pain has not worsened to a level requiring surgical treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR 75mg,quaque die(QD), for 12 consecutive weeks on demand. The other group receiving DICL-SR 75mg alone,quaque die(QD), for 12 consecutive weeks on demand. DICL-SR 75mg quaque die(QD) may be administered to the subjects of both groups on demand as long as they have a knee pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects. A total of 8 visits have been scheduled for this study, including Visit 1/screening period (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3), Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12). A total of 300 subjects will participate in this study at 6 to 8 centers in China, and patient enrollment is expected to take up to 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
ACTIVE_NOT_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGNanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGShanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGCompare the average daily doses (unit: pills) of the NSAID from Week9 (W9) to W12 between two groups
Time frame: From W9 to W12 (4 weeks)
Compare the average daily doses (unit: pills) of the NSAID from W5 to W8, and W5 to W12 between two groups
Time frame: From W5 to W8 (4 weeks), and W5 to W12 (8 weeks)
Compare the changes in the average daily doses (unit: pills) of the NSAID at the 8th and 12th week from baseline between two groups.
Time frame: At the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the percentage changes in the average daily doses (unit: pills) of the NSAID at the 8th and 12th week from baseline between two groups.
Time frame: At the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the days of NSAID consumption from W5 to W8, W9 to W12, and W5 to W12 between two groups.
Time frame: From W5 to W8 (4 weeks), W9 to W12 (4 weeks), and W5 to W12 (8 weeks)
Compare the changes in WOMAC A1 score (walk-associated pain), WOMAC A, B and C score and patient global assessment (PTGA) at the 4th, 8th and 12th week from baseline between two groups.
Time frame: At the 4th week from baseline (1 week), at the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
Compare the changes in clinical observer global assessment (COGA), and scores for activities of daily living (ADL) at the 4th, 8th and 12th week from baseline between two groups.
Time frame: At the 4th week from baseline (1 week), at the 8th week from baseline (1 week), and at the 12th week from baseline (1 week)
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