Knee osteoarthritis
Conditions
Interventions
Study Group: Indomethacin Gel Patch,1 patch each time, twice a day, for a continuous administration of 4 weeks.
Active Control Group: Indomethacin Gel Patch,1 patch each time, twice a day, for a continuous administration of 4 weeks.
Placebo Control Group:Indomethacin Gel Patch Simulator,1 patch each time, twice a day, for a continuous administration of 4 weeks.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 40-75 years (inclusive), any gender. 2. Meets the diagnostic criteria for knee osteoarthritis, with joint pain persisting for at least 1 month. 3. Able to walk without assistance at screening and during efficacy evaluations. 4. Target knee osteoarthritis graded as Kellgren-Lawrence grade I-III, with the contralateral knee grade not exceeding that of the target knee. 5. At randomization,The Western Ontario and McMaster Universities Osteoarthritis Index? pain subscore for "pain during walking on a flat surface" in the target knee must be >=40 mm and =225 mm. 6. Understands and agrees to comply with the study procedures, voluntarily participates, and provides signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Allergy to any component of the investigational product, or having an allergic constitution. 2.Other inflammatory or painful conditions of the knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumor, pigmented villonodular synovitis, joint trauma, septic arthritis, or tuberculous arthritis. 3.Osteoarthritis caused by osteomyelitis, bone tumor, or bone tuberculosis. 4.Late-stage lower limb joint deformity or disability. 5.Presence of skin lesions (e.g., broken skin, rash) at the target knee site. 6.Diseases of the bone, meniscus, muscle, blood vessels, or nerves in the target lower limb that may interfere with efficacy evaluation. 7.Frequent headaches or back pain within the past year requiring regular use of NSAIDs or other analgesics. 8.Open knee trauma, arthroscopy, joint lavage/debridement, joint replacement, or other knee surgeries within the past year. 9.Intra-articular injections (e.g., corticosteroids, hyaluronic acid, medical chitin, growth factors, platelet-rich plasma) into the target knee within the past 6 months. 10.Systemic corticosteroid or immunosuppressant use within the past 4 weeks. 11.Use of any Chinese or Western medications or therapies for osteoarthritis within 1 week prior to randomization (except acetaminophen). 12.History of upper gastrointestinal ulcer or bleeding within the past year. 13.History of aspirin-induced asthma or bronchial asthma. 14.Patients with severe primary cardiovascular, cerebrovascular, or hematopoietic system diseases. 15.Abnormal liver function (ALT or AST > 2× ULN) or renal dysfunction (Scr > 1.5× ULN). 16.History of high-risk alcohol consumption (alcoholism), drug abuse, or psychiatric disorders. 17.Pregnancy, planned pregnancy (within 3 months after trial completion), or lactation. 18.Participation in other drug or device clinical trials within the past month. 19.Poor compliance, inability to adhere to medication, or attend follow-up visits as scheduled. 20.Other conditions deemed by the investigator as unsuitable for clinical trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the western ontario and mcmaster universities osteoarthritis index pain score after 4 weeks of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline inthe western ontario and mcmaster universities osteoarthritis index pain score after 1 and 2 weeks of medication;Change from baseline in the western ontario and mcmaster universities osteoarthritis index stiffness score after 1, 2, and 4 weeks of medication;Change from baseline in the western ontario and mcmaster universities osteoarthritis index physical function score after 1, 2, and 4 weeks of medication;Change from baseline in the western ontario and mcmaster universities osteoarthritis index total score after 1, 2, and 4 weeks of medication;Rescue medication consumption during the treatment period; | — |
Countries
China
Contacts
Public ContactXu Weihua
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed