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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esflurbiprofen | Drug | A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm) |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Perisai Husada | Bandung | Indonesia | ||||
| Rumah Sakit Hasan Sadikin |
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| ID | Term |
|---|---|
| C000614065 | diclofenac diethylamine |
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| 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) |
|
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) |
| 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 |
| 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 | Indonesia |