UnknownPhase 2

A Trial of HRF2105 Patch in Relieving Pain of Osteoarthritis

90 participantsStarted 2023-10

Plain-language summary

The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis.

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Change in VAS score from baseline at the end of treatment Day7 on rising from the chair

Timeframe: Day7

NCT IDNCT06047483

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

Qin Liu

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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