A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis
NCT ID: NCT06047483
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2023-10-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HRF2105 patch
HRF2105 patch
HRF2105 patch ，external use，once a day
Loxoprofen patch
Loxoprofen patch
Loxoprofen patch ，external use，once a day
placebo
placebo
placebo ，external use，once a day
Interventions
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HRF2105 patch
HRF2105 patch ，external use，once a day
Loxoprofen patch
Loxoprofen patch ，external use，once a day
placebo
placebo ，external use，once a day
Eligibility Criteria
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Inclusion Criteria
2. Male or female
3. Meeting the diagnostic criteria of knee Articular bone osteoarthritis
4. The target knee joint meeting the VAS scoring requirements
5. K-L grading II-III，and the other knee joint grading is not higher than the target side
6. Able to walk without assistance
7. Willing to take contraceptive measures, female non pregnancy or lactation period
Exclusion Criteria
2. Active or high-risk bleeding diseases such as gastrointestinal ulcers may worsen due to the use of NSAIDs
3. Have a history of myocardial infarction or undergo coronary artery bypass grafting surgery
4. 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
5. The combination of mental illnesses such as depression, dementia, and schizophrenia has been determined by researchers to affect the efficacy evaluation of study drugs
6. Arthritis caused by other factors such as dermatomyositis, gouty arthritis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, purulent arthritis, systemic lupus erythematosus
7. 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
8. Severe osteoarthritis with obvious narrowing of joint space and indications for surgery
9. Pain in other areas that affect the evaluation of bone and joint pain, such as hip joint pain or lower back pain
10. Rashes and skin damage on the intended application of the study drug
11. Abnormal liver and kidney function, anemia or thrombocytopenia
12. 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
13. 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
14. 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
15. During the research process, physical therapy and rehabilitation therapy for the lower limbs or waist are required
16. Individuals with a history of allergies or contraindications to any component of this product or other losoprofen sodium preparations
17. During this period, alcohol, drugs, and drug withdrawal may affect the effectiveness and safety evaluation of the study drug
18. Participants in other clinical trials within 3 months
19. Family members of the subjects in this study (cohabiting)
20. Clinical research center employees directly involved in the operation, management, or support of this trial, or immediate family members
21. Other situations that the researcher determines are not suitable for participating in this clinical trial
40 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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HRF2105-201
Identifier Type: -
Identifier Source: org_study_id
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