Osteoarthritis of the Knee
Conditions
Interventions
test drug group:ibuprofen hydrochloride spray
active drug control group:Celecoxib Capsules
test drug group:Celecoxib placebo
active drug control group:ibuprofen hydrochloride spray placebo
placebo group:Celecoxib placebo
placebo group:ibuprofen hydrochloride spray placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 40 (inclusive) and 75 (inclusive); 2. It must be confirmed as primary knee osteoarthritis (OA) by clinical and/or imaging examination according to the standards of American Rheumatology Society, meeting at least 4 of the following 6 standards; 3. The medical history of knee OA with clinical symptoms should be = 6 months, and the X-ray film of knee joint can be provided to confirm the presence of hyperosteogeny or degeneration; 4. Knee joint pain occurred during standing, walking and/or exercise for at least 14 days within 1 month before screening; 5. Within 7 days before randomization, knee joint pain was scored by 100 mm VAS method without analgesics (except for rescue drugs designated in the study), and the score was = 40 mm and = 90 mm for at least 5 days (according to the records of the subject's diary card); 6. Before the first administration at the baseline visit (Day 1), the average WOMAC pain score of the target knee joint must be = 40 mm and = 90 mm; 7. The women participating in the study must be sterile (defined as at least 1 year after menopause, or have undergone sterilization [bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy]), or willing to use at least one of the following medically acceptable contraceptive methods:; 8. From the first visit in the screening period to the whole study treatment period, the subjects must avoid non habitual physical activities (such as starting a new weight lifting exercise); 9. Except for knee OA, the subjects were in good health; 10. Subjects can provide written signature and dated informed consent; 11. Be able to understand and willing to fully comply with the research process and program requirements.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to or have a history of allergy to Celecoxib, any other NSAIDs, aspirin, acetaminophen, sulfonamides or alcohol; Subjects did not tolerate NSAIDs or used NSAIDs regularly to treat OA, but the efficacy was poor; 2. The subject has a history of chronic pain (such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis, fibromyalgia), or other conditions that may affect the function of the target knee joint and pain assessment (such as bone necrosis, cartilage calcification); 3. The knee joint of the subject is secondary OA, or OA of lower limb joints other than the knee joint, which may affect the pain and function evaluation of the knee joint according to the judgment of the researcher; 4. Have a history of knee replacement, arthroplasty or other knee operations; 5. According to the judgment of the researcher, the subject had obvious injury involving the target knee joint within 6 months before screening; 6. There are skin lesions or wounds on or near the knee joint of the subject during the screening period or before the first use of the test drug (Day 1); 7. The subject is the target knee joint for treatment and has used opioids or glucocorticoids within 30 days before screening; Or those who need long-term treatment with opioids or glucocorticoids during the study period; 8. Within 3 months before the screening, the subject had received the treatment of intra-articular injection of steroids, hyaluronic acid, or adhesive (such as Xinweike) into the knee joint; 9. Subjects with asthma need systemic glucocorticoid treatment (asthma patients who only need inhaled glucocorticoid treatment can be selected); 10. Except that aspirin no more than 325 mg/day is used to prevent heart disease, subjects have used antithrombotic drugs within 1 month before screening; 11. Subjects had active peptic ulcer within 6 months before screening, or had a history of gastrointestinal bleeding within 5 years before screening; 12. Subjects are receiving systemic chemotherapy due to any type of active malignant tumor; Or, within 5 years before screening, cancer was diagnosed (excluding squamous cell carcinoma or basal cell carcinoma of skin); 13. According to the judgment of the investigator, the subject suffers from any clinically significant unstable heart, respiratory, neural, immune, blood, or kidney disease, or other clinically significant abnormalities in physical examination, medical history, electrocardiogram, and laboratory tests, which affect the evaluation of safety and efficacy. It is defined as: detection value of glutamic oxaloacetic transaminase, glutamic pyruvic transaminase and lactic dehydrogenase = 3 × Upper limit of normal value [ULN]; Creatinine or total bilirubin = 1.5 × ULN Hemoglobin 480 ms); Uncontrolled hypertension is defined as systolic blood pressure>170 mmHg or diastolic blood pressure>105 mmHg; 14. Subjects who are known to abuse alcohol or other drugs; 15. Subjects have participated in the clinical trial of ibulamine hydrochloride spray, or participated in any other clinical trial within 1 month before screening, or were within 5 metabolic half lives of other clinical trial drugs at the time of screening; 16. Female subject,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC score;VAS scale;Knee joint effusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject's assessment of OA condition;Subject's assessment of treatment effect;Number of acetaminophen tablets to use; | — |
Countries
China
Contacts
Public ContactZeng Xiaofeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed