JPRN-jRCTs031180228已完成未知
To Investigate the agents concentration in tissues after administration of Esflurbiprofen tape and Flurbiprofen in patients with knee osteoarthritis: Multi-centered Randomized study - Multicentered Randomized study for knee osteoarthritis
Koga Hideyuki0 个研究点目标入组 52 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
The study drug (esflurbiprofen plaster: SFPP) group showed relatively high tissue migration in synovial membrane, about 88.1% of the control (flurbiprofen tablet: FPT) group. SFPP has improved transdermal absorbability over conventional drugs. Thus, SFPP might had tissue migration similar to that of FPT. There were no serious adverse events. It was suggested that SPPP has a high ability to migrate to deep tissues, and that SFPP has different characteristics from the conventional evaluation of NSAIDs.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who meet all of the following selection criteria are included in the study
- •1. Patients with knee osteoarthritis who are planning to replace artificial knee joints on one knee or both knees
- •2. Patients aged 20 years or older at the time of consent acquisition
- •3. Patients who fully understand the research, have received sufficient explanation of participation, patients who obtained written informed consent with free choice.
排除标准
- •Patients who meet any of the following conditions are excluded from the study
- •1.Patients with surgical history of the knee to be evaluated, and considered that it may affect to the outcome
- •2.Patients complicated with rheumatoid arthritis
- •3.Patient who is scheduled to receive the following treatment within 7 days before administration , Injection of analgesic , Intraarticular injection (hyaluronic acid, corticosteroid drug, local anesthetic) , Use of systemic corticosteroid drug (injection, oral) , evaluation Puncture to the knee, drainage, arthroscopy
- •4.Patients who requires shaving of knee to be evaluated for the surgery
- •5.Patients who are receiving or planning to receive treatment with agents that interact with Esflurbiprofen and Flurbiprofen (such as CYP 2C9 inducers)
- •6.Patient who has a history of atopic dermatitis or complication of atopic dermatitis
- •7.Patients with skin disorder such as eczema on the knee to be evaluated
- •8.Patients who have developed skin disorders by using patches
- •9.Patients complicated with infectious diseases (hepatitis C, HIV infection etc.)
- •10.Patients for whom administration is prohibited and / or patients who require cautious administration as listed in the latest package insert
- •11.Women who are currently pregnant or may be pregnant
- •12.Women who are during lactation period
- •13.Patients who are difficult to consent to the study(dementia, disturbance of consciousness etc.)
- •14.Patients who were judged by investigators to be inappropriate for participation in the study
研究者
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