Status:
UNKNOWN
A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Analgesia and Anti-inflammatory of Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis.
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Male or female
- Meeting the diagnostic criteria of knee Articular bone osteoarthritis
- The target knee joint meeting the VAS scoring requirements
- K-L grading II-III，and the other knee joint grading is not higher than the target side
- Able to walk without assistance
- Willing to take contraceptive measures, female non pregnancy or lactation period
Exclusion
- Concomitant bronchial asthma; Previous aspirin induced asthma (non steroidal anti-inflammatory drugs induced asthma)
- Active or high-risk bleeding diseases such as gastrointestinal ulcers may worsen due to the use of NSAIDs
- Have a history of myocardial infarction or undergo coronary artery bypass grafting surgery
- Having serious cardiovascular, cerebrovascular, hematopoietic, metabolic system diseases or malignant tumors, as determined by the researcher, it is not suitable to participate in this study
- The combination of mental illnesses such as depression, dementia, and schizophrenia has been determined by researchers to affect the efficacy evaluation of study drugs
- Arthritis caused by other factors such as dermatomyositis, gouty arthritis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, purulent arthritis, systemic lupus erythematosus
- In addition to the knee joint, complications such as goose foot bursitis, intermittent claudication, and other conditions that can cause pain in the knee joint area
- Severe osteoarthritis with obvious narrowing of joint space and indications for surgery
- Pain in other areas that affect the evaluation of bone and joint pain, such as hip joint pain or lower back pain
- Rashes and skin damage on the intended application of the study drug
- Abnormal liver and kidney function, anemia or thrombocytopenia
- Within one year prior to signing the ICF, either side of the knee joint experienced open knee injury or underwent other knee joint surgeries such as arthroscopy, arthroscopic debridement, knee replacement, etc
- Patients who have received intra-articular drug injection therapy (such as glucocorticoids, sodium hyaluronate, medical chitosan, growth factors, and platelet rich plasma) on either side of the knee joint within 3 months prior to signing the ICF
- Within the first 5 days of randomization or during the study period, other drugs for treating osteoarthritis need to be used except the study drug
- During the research process, physical therapy and rehabilitation therapy for the lower limbs or waist are required
- Individuals with a history of allergies or contraindications to any component of this product or other losoprofen sodium preparations
- During this period, alcohol, drugs, and drug withdrawal may affect the effectiveness and safety evaluation of the study drug
- Participants in other clinical trials within 3 months
- Family members of the subjects in this study (cohabiting)
- Clinical research center employees directly involved in the operation, management, or support of this trial, or immediate family members
- Other situations that the researcher determines are not suitable for participating in this clinical trial
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06047483
Start Date
October 1 2023
End Date
December 1 2023
Last Update
September 21 2023
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