Clinical trial NCT03434197: Safety and Efficacy of SFPP in Knee Osteoarthritis
Official title: Randomized Controlled Study to Evaluate the Safety and Efficacy of SFPP in Knee Osteoarthritis Using Diclofenac Gel as the Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis Knee Pain
Keywords: Osteoarthritis Knee Pain
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 313
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of Knee pain on rising from the chair
timeFrame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
Secondary outcomes:
measure: Improvement of Changes in total clinical symptom
timeFrame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
measure: Improvement of Investigator's global assessment
timeFrame: Last visit
measure: Improvement of Patient's global assessment
timeFrame: Last visit
measure: Improvement of Knee pain on walking
timeFrame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
measure: Number of Rescue drug use during treatment period
timeFrame: 3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period)
measure: Number of Adverse events and adverse drug reactions
timeFrame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Klinik Perisai Husada
city: Bandung
country: Indonesia
facility: Rumah Sakit Hasan Sadikin
city: Bandung
country: Indonesia
facility: Rumah Sakit Umum Daerah Al Ihsan Bale Endah
city: Jakarta
country: Indonesia
facility: Rumah Sakit Anna Medika Bekasi
city: Jakarta
country: Indonesia
facility: Rumah Sakit Cipto Mangunkusumo
city: Jakarta
country: Indonesia
facility: Rumah Sakit Islam Pd. Kopi
city: Jakarta
country: Indonesia
facility: Rumah Sakit Siloam Karawaci
city: Malang
country: Indonesia
facility: Rheumatology and Allergy Clinic
city: Malang
country: Indonesia
facility: Rumah Sakit UD Dr. Saiful Anwar
city: Surabaya
country: Indonesia
facility: Rumah Sakit TNI AU Soemitro
city: Surabaya
country: Indonesia
facility: Rumah Sakit UD Dr. Soetomo
Study officials:
affiliation: Rumah Sakit Cipto Mangunkusumo
name: Bambang Setyohadi, Dr. Sp.PD-KR
role: STUDY_CHAIR
affiliation: Rumah Sakit Cipto Mangunkusumo
name: Sumariyono, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit Islam Pd. Kopi
name: Tanggo Meriza, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit Siloam Karawaci
name: Sandra Sinthya Langow, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit Anna Medika Bekasi
name: Ika Wulan Yuliani, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit Hasan Sadikin
name: Sumartini Dewi, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit Umum Daerah Al Ihsan Bale Endah
name: Andri Reza, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik Perisai Husada
name: Laniyati Hamijoyo, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit UD Dr. Soetomo
name: Yuliasih, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit TNI AU Soemitro
name: Lita Diah Rahmawati, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rumah Sakit UD Dr. Saiful Anwar
name: Cesarius Singgih Wahono, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology and Allergy Clinic
name: Handono Kalim, Dr. Sp.PD-KR
role: PRINCIPAL_INVESTIGATOR
References: