Safety and Efficacy of SFPP in Knee Osteoarthritis

Taisho Pharmaceutical Co., Ltd.313 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

313

Conditions

Osteoarthritis Knee Pain

Interventions

EsflurbiprofenDRUG

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

Diclofenac diethylamineDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Improvement of Knee pain on rising from the chair

0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

Time frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Secondary Outcomes

Improvement of Changes in total clinical symptom

Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 )

Time frame: 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)

Time frame: Last visit

Improvement of Patient's global assessment

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

Time frame: Last visit

Improvement of Knee pain on walking

0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

Time frame: 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

Time frame: 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

Time frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Data from ClinicalTrials.gov

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