Safety and Efficacy of SFPP in Knee Osteoarthritis

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.

Conditions

• Osteoarthritis Knee Pain

Interventions

DRUG

Esflurbiprofen

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

DRUG

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)

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Bambang Setyohadi, Dr. Sp.PD-KR · Rumah Sakit Cipto Mangunkusumo

• Sumariyono, Dr. Sp.PD-KR · Rumah Sakit Cipto Mangunkusumo

• Tanggo Meriza, Dr. Sp.PD-KR · Rumah Sakit Islam Pd. Kopi

• Sandra Sinthya Langow, Dr. Sp.PD-KR · Rumah Sakit Siloam Karawaci

• Ika Wulan Yuliani, Dr. Sp.PD-KR · Rumah Sakit Anna Medika Bekasi

• Sumartini Dewi, Dr. Sp.PD-KR · Rumah Sakit Hasan Sadikin

• Andri Reza, Dr. Sp.PD-KR · Rumah Sakit Umum Daerah Al Ihsan Bale Endah

• Laniyati Hamijoyo, Dr. Sp.PD-KR · Klinik Perisai Husada

• Yuliasih, Dr. Sp.PD-KR · Rumah Sakit UD Dr. Soetomo

• Lita Diah Rahmawati, Dr. Sp.PD-KR · Rumah Sakit TNI AU Soemitro

• Cesarius Singgih Wahono, Dr. Sp.PD-KR · Rumah Sakit UD Dr. Saiful Anwar

• Handono Kalim, Dr. Sp.PD-KR · Rheumatology and Allergy Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-05

Primary Completion

2021-01-11

Completion

2021-01-11

Countries

• Indonesia

Study Locations