Status:
COMPLETED
Safety and Efficacy of SFPP in Knee Osteoarthritis
Lead Sponsor:
Taisho Pharmaceutical Co., Ltd.
Conditions:
Osteoarthritis Knee Pain
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2021
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT03434197
Start Date
February 5 2018
End Date
January 11 2021
Last Update
August 20 2021
Active Locations (11)
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1
Klinik Perisai Husada
Bandung, Indonesia
2
Rumah Sakit Hasan Sadikin
Bandung, Indonesia
3
Rumah Sakit Umum Daerah Al Ihsan Bale Endah
Bandung, Indonesia
4
Rumah Sakit Anna Medika Bekasi
Jakarta, Indonesia