Moderate Pain in Knee Osteoarthritis, Severe Pain in Knee Osteoarthritis
Conditions
Brief summary
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.
Interventions
DRUGHRS-2129 Tablet
HRS-2129 tablet.
Celecoxib capsule.
DRUGCelecoxib Capsule Placebo
Celecoxib capsule placebo.
DRUGHRS-2129 Tablet Placebo
HRS-2129 tablet placebo.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Comparison between HRS-2129 high dose group, HRS-2129 low dose group, Celecoxib positive control group, and Placebo control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form before starting the activities related to the trial; 2. The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4; 3. Subjects must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ; 4. Male and female subjects of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of investigational product.
Exclusion criteria
1. History of other diseases that may involve the target joint; 2. History of major trauma or surgery of knee joint and hip joint in the past year; 3. Plan to undergo surgical procedure during the study; 4. Most or complete loss of mobility; 5. There are other diseases that may confuse the assessment of osteoarthritis pain; 6. There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score; 7. There are serious or poorly controlled concomitant diseases; 8. Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed; 9. Those who require drug treatment or surgical intervention; 10. History of malignant tumors within 5 years before screening; 11. Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. | At week 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. | From baseline to Week 1, 2 and 3. | — |
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores. | 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). | 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). | 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. | From baseline to Week 1, 2, 3 and 4. | — |
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores. | From baseline to Week 1, 2, 3 and 4. | — |
| Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. | From baseline to Week 1, 2, 3 and 4. | — |
| Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline. | At Week 1, 2, 3 and 4. | — |
| Adverse events (AEs) occurred during the study. | During the study, approximately 8 months. | To evaluate the safety and tolerability of HRS-2129 tablets. |
| Serious adverse events (SAEs) occurred during the study. | During the study, approximately 8 months. | To evaluate the safety and tolerability of HRS-2129 tablets. |
Countries
China
Contacts
CONTACTZhuang Nie
Outcome results
None listed