Safety and Efficacy of SFPP in Knee Osteoarthritis

NCT03434197 | Completed Phase 3

• 1 other identifier: TPJ.01.2017
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 11

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.

Conditions

Osteoarthritis Knee Pain

Keywords

Osteoarthritis Knee Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Improvement of Changes in total clinical symptom

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

• Improvement of Investigator's global assessment

  Last visit

• Improvement of Patient's global assessment

  Last visit

• Improvement of Knee pain on walking

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

• Number of Rescue drug use during treatment period

  3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period)

Study Arms (2)

SFPP (Esflurbiprofen plaster)

EXPERIMENTAL

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

Drug: Esflurbiprofen

Diclofenac gel

ACTIVE COMPARATOR

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

Interventions

Esflurbiprofen DRUG

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

SFPP (Esflurbiprofen plaster)

Diclofenac diethylamine DRUG

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

Diclofenac gel

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (11)

Klinik Perisai Husada

Bandung, Indonesia

Location

Rumah Sakit Hasan Sadikin

Bandung, Indonesia

Location

Rumah Sakit Umum Daerah Al Ihsan Bale Endah

Bandung, Indonesia

Location

Rumah Sakit Anna Medika Bekasi

Jakarta, Indonesia

Location

Rumah Sakit Cipto Mangunkusumo

Jakarta, Indonesia

Location

Rumah Sakit Islam Pd. Kopi

Jakarta, Indonesia

Location

Rumah Sakit Siloam Karawaci

Jakarta, Indonesia

Location

Rheumatology and Allergy Clinic

Malang, Indonesia

Location

Rumah Sakit UD Dr. Saiful Anwar

Malang, Indonesia

Location

Rumah Sakit TNI AU Soemitro

Surabaya, Indonesia

Location

Rumah Sakit UD Dr. Soetomo

Surabaya, Indonesia

Location

MeSH Terms

Interventions

diclofenac diethylamine

Study Officials

• Bambang Setyohadi, Dr. Sp.PD-KR

  Rumah Sakit Cipto Mangunkusumo

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 15, 2018
• Study Start: February 5, 2018
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (11)