Safety and Efficacy of SFPP in Knee Osteoarthritis

Taisho Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis Knee Pain

Treatments: Drug: Esflurbiprofen; Drug: Diclofenac diethylamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03434197

TPJ.01.2017

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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313 participants in 2 patient groups

SFPP (Esflurbiprofen plaster)

Experimental group

Description:

A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)

Treatment:

Drug: Esflurbiprofen

Diclofenac gel

Active Comparator group

Description:

A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)

Treatment:

Drug: Diclofenac diethylamine