Osteoarthritis Knee Pain
Conditions
Keywords
Osteoarthritis Knee Pain
Brief summary
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.
Interventions
DRUGEsflurbiprofen
A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
DRUGDiclofenac diethylamine
A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Knee pain on rising from the chair | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | 0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Investigator's global assessment | Last visit | Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse) |
| Improvement of Patient's global assessment | Last visit | Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse ) |
| Improvement of Changes in total clinical symptom | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 ) |
| Number of Rescue drug use during treatment period | 3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period) | Report from investigator |
| Number of Adverse events and adverse drug reactions | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | Report from investigator |
| Improvement of Knee pain on walking | 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) | 0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever) |
Countries
Indonesia
Outcome results
None listed