Safety and Efficacy of SFPP in Knee Osteoarthritis
- Conditions
- Osteoarthritis Knee Pain
- Interventions
- Registration Number
- NCT03434197
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 313
- 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
- Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diclofenac gel Diclofenac 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) SFPP (Esflurbiprofen plaster) Esflurbiprofen A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 )
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 Investigator's global assessment Last visit Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)
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)
Trial Locations
- Locations (11)
Klinik Perisai Husada
🇮🇩Bandung, Indonesia
Rumah Sakit TNI AU Soemitro
🇮🇩Surabaya, Indonesia
Rumah Sakit Islam Pd. Kopi
🇮🇩Jakarta, Indonesia
Rumah Sakit Hasan Sadikin
🇮🇩Bandung, Indonesia
Rumah Sakit Umum Daerah Al Ihsan Bale Endah
🇮🇩Bandung, Indonesia
Rumah Sakit Cipto Mangunkusumo
🇮🇩Jakarta, Indonesia
Rumah Sakit Siloam Karawaci
🇮🇩Jakarta, Indonesia
Rumah Sakit Anna Medika Bekasi
🇮🇩Jakarta, Indonesia
Rumah Sakit UD Dr. Saiful Anwar
🇮🇩Malang, Indonesia
Rheumatology and Allergy Clinic
🇮🇩Malang, Indonesia
Rumah Sakit UD Dr. Soetomo
🇮🇩Surabaya, Indonesia