Knee pain in patient with moderate to severe knee OA (Kallgren-Lawrence type III - IV) Knee pain, Moderate to severe knee osteoarthritis, Kallgren-Lawrence type III - IV
Conditions
Interventions
- The patients will have S-flurbiprofen plaster (SFPP) containing 40 mg of SFP in a 10 x 14 cm tape-type patch to apply once daily to the affected area
- Rescue drugs during the treatment period are a
Active Comparator Drug,Placebo Comparator Drug
S-flurbiprofen plaster,Placebo
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 50 - 75 years 2. Able to understand and use Thai language for communication (reading, speaking, writing) 3. Kallgren-Lawrence Grade III or IV osteoarthritis in target knee 4. Able to walk 5. Understood the visual analog scales (VAS) and able to fill the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Exclusion criteria
Exclusion criteria: 1. Had past surgery in target knee 2. Received treatment including corticosteroids or intra-articular injection to the target knee within 14 days 3. History of hypersensitivity or allergy to NSAIDs, aspirin-induced asthma 4. History of dermatitis requiring treatment by any patch formulation 5. Pregnant, potentially pregnant or lactating women 6. Had other comorbidities: Neuropsychiatric disorder, dementia, renal failure (CrCl < 30 mL/min/1.73 m2), severe hypertension, peptic ulcer, skin disease, liver disease, severe blood disease, cardiac disease, infectious disease using quinolone antibiotics (e.g. norfloxacin), patients using precaution drugs (e.g. warfarin, LMWH, TCA, SSRI, SNRI,, immunosuppressive drugs; cyclosporine, methotrexate, anti-retroviral drugs; tenofovir) 7. Chronic pain patients using more potent pain control drug e.g. opioid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain levels at 1 week, 2 weeks and 4 weeks (2 weeks free of treatment) after starting the therapy The changes in visual analog scale (VAS) scores (0-100 mm) for pain levels ,Knee function at 1 week, 2 weeks and 4 weeks (2 weeks free of treatment) after starting the therapy The changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects at 1 week, 2 weeks and 4 weeks (2 weeks free of treatment) after starting the therapy The adverse events complaint recorded in each appointment | — |
Countries
Thailand
Contacts
Public ContactVarah Yuenyongviwat
Prince of Songkla Univeristy
Outcome results
None listed