MedPath

Safety and Efficacy of SFPP in Knee Osteoarthritis

Phase 3
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Diclofenac gelDiclofenac diethylamineA 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)EsflurbiprofenA plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
Primary Outcome Measures
NameTimeMethod
Improvement of Knee pain on rising from the chair5 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
NameTimeMethod
Improvement of Changes in total clinical symptom5 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 assessmentLast visit

Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )

Improvement of Investigator's global assessmentLast visit

Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)

Number of Rescue drug use during treatment period3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period)

Report from investigator

Number of Adverse events and adverse drug reactions5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Report from investigator

Improvement of Knee pain on walking5 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 Hasan Sadikin

🇮🇩

Bandung, Indonesia

Rumah Sakit Umum Daerah Al Ihsan Bale Endah

🇮🇩

Bandung, Indonesia

Rumah Sakit Anna Medika Bekasi

🇮🇩

Jakarta, Indonesia

Rumah Sakit Cipto Mangunkusumo

🇮🇩

Jakarta, Indonesia

Rumah Sakit Islam Pd. Kopi

🇮🇩

Jakarta, Indonesia

Rumah Sakit Siloam Karawaci

🇮🇩

Jakarta, Indonesia

Rheumatology and Allergy Clinic

🇮🇩

Malang, Indonesia

Rumah Sakit UD Dr. Saiful Anwar

🇮🇩

Malang, Indonesia

Rumah Sakit TNI AU Soemitro

🇮🇩

Surabaya, Indonesia

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Klinik Perisai Husada
🇮🇩Bandung, Indonesia

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