NCT06047483尚未招募2 期
A Multicenter, Randomized, Single Blind, Positive Drug and Placebo Parallel Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of HRF2105patch in Relieving Pain of Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Change in VAS score from baseline at the end of treatment Day7 on rising from the chair
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of HRF2105patch in relieving pain of Osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HRF2105 patch
Experimental
干预措施: HRF2105 patch (Drug)
Loxoprofen patch
Active Comparator
干预措施: Loxoprofen patch (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in VAS score from baseline at the end of treatment Day7 on rising from the chair
时间窗: Day7
次要结局
- Change in WOMAC pain score from baseline at the end of treatment (Day7)(Day7)
- Daily average dose of remedial drug (Paracetamol) during the treatment period(Day0-Day7)
- Researcher satisfaction score(Day7)
- Skin irritation and sensitization scores(Day0-Day7)
- Change in WOMAC stiffness score from baseline at the end of treatment (Day7)(Day7)
- Change in WOMAC daily activity score from baseline at the end of treatment (Day7)(Day7)
- Change in WOMAC total score from baseline at the end of treatment (Day7)(Day7)
- Subject satisfaction score(Day7)
研究者
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