knee osteoarthritis
Conditions
Interventions
Esflurbiprofen tape
1. [Dosage and administration] Apply one plaster to affected area once daily
2. [Dosing conditions] Apply to the knee to be evaluated which was determined at the start of the study
Sponsors
Koga Hideyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Agent concentration in tissue | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in NRS [Numerical Rating Scale] | — |
Contacts
Public ContactMasaki Amemiya
Tokyo Medical and Dental University
Outcome results
None listed