Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females 40 to 80 years of age. 2. The ACR Criteria for osteoarthritis of the knee. 3. Radiographic evidence of OA, Kellgren and Lawrence grade 1 to 3 on prior X-rays at screening. Only the tibio-femoral joint will be evaluated. 4. Chronic pain for at least 1 month prior to study entry (WOMAC pain score)
Exclusion criteria
Exclusion criteria: 1. An intra-articu1ar knee injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months. 2. A history of crystalline arthropathy or inflammatory arthritis, neutopathic arthropathy. 3. A current other problem in the affected extremity. 4. A history of clinically significant trauma or surgery. 5. Allergy or hypersensitivity to any of the study medications. 6. Joint effusion. 7. Non comp1iance to the study procedures and or non completion of the study according to investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC pain, function score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual Analog Scale 2. EQ5D 3. KOACAD parameter on plain knee radiograph | — |
Countries
Japan
Contacts
Faculty of Medicine, University of Tokyo 22nd Century Medical Center