Knee osteoarthritis
Conditions
Interventions
Experimental group:Treatment period (2w): Dexketoprofen sustained-release patch
Control group:Treatment period (2w): Loxoprofen sodium patch
Placebo group:Treatment period (2w):Placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40 to 75 years old patients, male and female; 2. The body mass index (BMI) of subjects ranged from 19 (including) to 35 (including) kg / m2; 3. Patients who meet the criteria of the guide for diagnosis and treatment of osteoarthritis (2018 Edition) are diagnosed as knee osteoarthritis (KOA) by clinical and imaging examination (imaging examination results within one month before screening are acceptable); 4. Patients whose history of clinical symptoms of knee OA should be >=1 month; 5. Within 7 days before randomization, patients with knee joint pain who did not use analgesics had VAS pain score >= 4 and < 8; 6. The subjects understood and followed the research process, participated voluntarily and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. According to the researchers, the knee joints of the subjects were deformable osteoarthritis (peggit's osteopathy), joint fracture, severe dysplasia or congenital abnormality, brown disease, lupus, acromegaly, hemochromatosis, hepatolenticular degeneration, primary chondromatosis, or OA of the lower limb joints outside the knee joint, which may affect the pain and function evaluation of the knee joint; 2. It was determined by the investigator or local radiologist during the screening period that the subjects had OA of the knee joint, and the imaging grade of the knee joint in the study side was 0 or 4; 3. Patients with asthma who need systemic glucocorticoid treatment (but only those who need inhaled glucocorticoid to treat asthma can be selected); or those who have other allergic reactions such as urticaria and angioedema after taking aspirin or non steroidal anti-inflammatory drugs; right-handed ketoprofen, or ketoprofen like drugs, or in any form Those who are intolerant to or allergic to the pharmaceutical excipients; 4. In the screening period, or before the first use of the test drug (day 1), patients with skin damage, skin diseases or wounds, and other symptoms; 5. Patients who have been treated with acupuncture, interventional therapy and local blocking therapy one week before treatment; 6. Those patients with long-term half-life NSAIDs, opioids, or corticosteroids used or planned to be used during the study within 30 days before re screening; 7. Patients with severe gastrointestinal dysfunction, active peptic ulcer within 6 months before screening, or gastrointestinal bleeding within 5 years at screening, serious cardiovascular or peripheral vascular diseases, liver and kidney dysfunction (AST, ALT > 1.5 times of the upper limit of normal, blood creatinine > the upper limit of normal), hemorrhagic diseases, coagulation dysfunction, etc; 8. At baseline, subjects had uncontrollable hypertension, defined as systolic > 170 mmHg, and diastolic > 90 mmHg (remeasurable after 5 minutes of rest); 9. Except aspirin not more than 325 mg / day was used to prevent heart disease, the subjects used anticoagulant within 1 month before screening; 10. The patients with abnormal nerve function caused by abnormal limb function; 11. Patients with serious metabolic diseases and endocrine diseases; 12. Patients with a history of chronic inflammatory diseases (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis, fibromyalgia), or other conditions that may affect the target joint, or its function and pain assessment (such as osteonecrosis, cartilage calcification); 13. Lactating or pregnant women; 14. Patients (except celecoxib, meloxicam, nabumetone and other long-term half-life drugs) or painkillers (except those whose daily dose of paracetamol tablet is not more than 2000mg), cartilage protective drugs, etc. (taking cartilage protective drugs continuously for 3 months before screening, and agree to Except for those who continued to take such drugs during the study period); 15. To screen the patients who had received intraluminal steroid injection, viscoelastic supplement or arthroscopy in the first 3 months; 16. Patients with trauma or surgery within 6 months before the study side knee joint screening; 17. Subjects participated in any other clinical trials within the past 3 months; 18. Subjects with known alcohol or drug abuse; 19. In the opinion of the investigator, any patient who endangers the safety of the su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC scale pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC scale stiff part score;WOMAC scale dysfunction partial score;WOMAC scale total score; | — |
Contacts
Public ContactHui Wen
Zhejiang Asia Pacific Pharmaceutical Co., Ltd
Outcome results
None listed