Safety and Efficacy of SFPP in Knee Osteoarthritis

Randomized Controlled Study to Evaluate the Safety and Efficacy of SFPP in Knee Osteoarthritis Using Diclofenac Gel as the Comparator

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 Overview

• Status: Completed
• Conditions: Osteoarthritis Knee Pain
• Intervention / Treatment: Drug: Esflurbiprofen; Drug: Diclofenac diethylamine

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Bandung, Indonesia
    • Klinik Perisai Husada
  • Bandung, Indonesia
    • Rumah Sakit Hasan Sadikin
  • Bandung, Indonesia
    • Rumah Sakit Umum Daerah Al Ihsan Bale Endah
  • Jakarta, 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
  • Malang, Indonesia
    • Rheumatology and Allergy Clinic
  • Malang, Indonesia
    • Rumah Sakit UD Dr. Saiful Anwar
  • Surabaya, Indonesia
    • Rumah Sakit TNI AU Soemitro
  • Surabaya, Indonesia
    • Rumah Sakit UD Dr. Soetomo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SFPP (Esflurbiprofen plaster); A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)	Drug: Esflurbiprofen; A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
Active Comparator: Diclofenac gel; A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Knee pain on rising from the chair	0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)	5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Changes in total clinical symptom	Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 )	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)	Last visit
Improvement of Patient's global assessment	Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )	Last visit
Improvement of Knee pain on walking	0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)	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	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	5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Bambang Setyohadi, Dr. Sp.PD-KR, Rumah Sakit Cipto Mangunkusumo; Principal Investigator: Sumariyono, Dr. Sp.PD-KR, Rumah Sakit Cipto Mangunkusumo; Principal Investigator: Tanggo Meriza, Dr. Sp.PD-KR, Rumah Sakit Islam Pd. Kopi; Principal Investigator: Sandra Sinthya Langow, Dr. Sp.PD-KR, Rumah Sakit Siloam Karawaci; Principal Investigator: Ika Wulan Yuliani, Dr. Sp.PD-KR, Rumah Sakit Anna Medika Bekasi; Principal Investigator: Sumartini Dewi, Dr. Sp.PD-KR, Rumah Sakit Hasan Sadikin; Principal Investigator: Andri Reza, Dr. Sp.PD-KR, Rumah Sakit Umum Daerah Al Ihsan Bale Endah; Principal Investigator: Laniyati Hamijoyo, Dr. Sp.PD-KR, Klinik Perisai Husada; Principal Investigator: Yuliasih, Dr. Sp.PD-KR, Rumah Sakit UD Dr. Soetomo; Principal Investigator: Lita Diah Rahmawati, Dr. Sp.PD-KR, Rumah Sakit TNI AU Soemitro; Principal Investigator: Cesarius Singgih Wahono, Dr. Sp.PD-KR, Rumah Sakit UD Dr. Saiful Anwar; Principal Investigator: Handono Kalim, Dr. Sp.PD-KR, Rheumatology and Allergy Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Osteoarthritis Knee Pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: TPJ.01.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No