Safety and Efficacy of SFPP in Knee Osteoarthritis

Study Overview
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Brief Summary
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The objectives of this study are to demonstrate the non-inferiority of esflurbiprofen plaster (SFPP) 40 mg applied for 2 weeks to diclofenac gel, the comparator, in terms of efficacy in patients with knee osteoarthritis (OA) and to examine the safety of SFPP.

Official Title
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Randomized Controlled Study to Evaluate the Safety and Efficacy of SFPP in Knee Osteoarthritis Using Diclofenac Gel as the Comparator

Conditions
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Osteoarthritis Knee Pain

Intervention / Treatment
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* Drug: Esflurbiprofen
* Drug: Diclofenac diethylamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had unilateral knee pain and were classified as Grade II or III according to Kellgren-Lawrence (KL) grading and whose non-assessed knee is not graded higher than the assessed knee based on x-ray in standing, weight-bearing extension position within 90 days before screening visit (1st visit) Patients whose knee pain on rising from the chair assessed by visual analogue scale (rVAS) of the assessed knee meets all the following criteria for the level of pain; < 80 mm at washout visit (2nd visit), ≥ 40 mm at baseline visit (3rd visit), Worsening of ≥ 15 mm at baseline visit (3rd visit) compared with rVAS at washout visit (2nd visit) as a result of discontinuation of use of NSAIDs Exclusion Criteria: Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SFPP (Esflurbiprofen plaster)<br>A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm) | Drug: Esflurbiprofen<br>* A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)<br>|
| Active Comparator: Diclofenac gel<br>A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g) | Drug: Diclofenac diethylamine<br>* A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Knee pain on rising from the chair | 0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever) | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Changes in total clinical symptom | Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 ) | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | 
| Improvement of Investigator's global assessment | Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse) | Last visit | 
| Improvement of Patient's global assessment | Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse ) | Last visit | 
| Improvement of Knee pain on walking | 0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever) | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | 
| Number of Rescue drug use during treatment period | Report from investigator | 3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period) | 
| Number of Adverse events and adverse drug reactions | Report from investigator | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis Knee Pain