Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Drum Tower Hospital affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, China
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Time frame: At week 4.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Time frame: From baseline to Week 1, 2 and 3.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting).
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking).
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale.
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores.
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Time frame: From baseline to Week 1, 2, 3 and 4.
Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.
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HRS-2129 tablet placebo.
Time frame: At Week 1, 2, 3 and 4.
Adverse events (AEs) occurred during the study.
To evaluate the safety and tolerability of HRS-2129 tablets.
Time frame: During the study, approximately 8 months.
Serious adverse events (SAEs) occurred during the study.
To evaluate the safety and tolerability of HRS-2129 tablets.
Time frame: During the study, approximately 8 months.