Safety and Efficacy of SFPP in Knee Osteoarthritis

Osteoarthritis Knee Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434197
• Other study ID #: TPJ.01.2017
• Status: Completed
• Phase: Phase 3
• Start date: February 5, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: August 2021
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee Pain
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Indonesia	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	Jakarta
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta
Indonesia	Rumah Sakit Islam Pd. Kopi	Jakarta
Indonesia	Rumah Sakit Siloam Karawaci	Jakarta
Indonesia	Rheumatology and Allergy Clinic	Malang
Indonesia	Rumah Sakit UD Dr. Saiful Anwar	Malang
Indonesia	Rumah Sakit TNI AU Soemitro	Surabaya
Indonesia	Rumah Sakit UD Dr. Soetomo	Surabaya

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Improvement of Investigator's global assessment	Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)	Last visit
Secondary	Improvement of Patient's global assessment	Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )	Last visit
Secondary	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)
Secondary	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)
Secondary	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)