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Safety and Efficacy of SFPP in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434197
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Taisho Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Knee Pain Drug: Esflurbiprofen Drug: Diclofenac diethylamine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Evaluate the Safety and Efficacy of SFPP in Knee Osteoarthritis Using Diclofenac Gel as the Comparator
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: SFPP (Esflurbiprofen plaster)
A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
Drug: Esflurbiprofen
A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)

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




Primary Outcome Measures :
  1. Improvement of Knee pain on rising from the chair [ Time Frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) ]
    0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)


Secondary Outcome Measures :
  1. Improvement of Changes in total clinical symptom [ Time Frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) ]
    Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 )

  2. Improvement of Investigator's global assessment [ Time Frame: Last visit ]
    Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)

  3. Improvement of Patient's global assessment [ Time Frame: Last visit ]
    Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )

  4. Improvement of Knee pain on walking [ Time Frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) ]
    0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

  5. Number of Rescue drug use during treatment period [ Time Frame: 3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period) ]
    Report from investigator

  6. Number of Adverse events and adverse drug reactions [ Time Frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period) ]
    Report from investigator



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434197


Contacts
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Contact: Kenji Tomatsu +819034038870 k-tomatsu@taisho.co.jp

Locations
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Indonesia
Klinik Perisai Husada Recruiting
Bandung, Indonesia
Contact: Laniyati Hamijoyo, Dr. Sp.PD-KR         
Rumah Sakit Hasan Sadikin Recruiting
Bandung, Indonesia
Contact: Sumartini Dewi, Dr. Sp.PD-KR         
Rumah Sakit Umum Daerah Al Ihsan Bale Endah Recruiting
Bandung, Indonesia
Contact: Andri Reza, Dr. Sp.PD-KR         
Rumah Sakit Anna Medika Bekasi Recruiting
Jakarta, Indonesia
Contact: Ika Wulan Yuliani, Dr. Sp.PD-KR         
Rumah Sakit Cipto Mangunkusumo Recruiting
Jakarta, Indonesia
Contact: Sumariyono, Dr. Sp.PD-KR         
Rumah Sakit Islam Pd. Kopi Recruiting
Jakarta, Indonesia
Contact: Tanggo Meriza, Dr. Sp.PD-KR         
Rumah Sakit Siloam Karawaci Recruiting
Jakarta, Indonesia
Contact: Sandra Sinthya Langow, Dr. Sp.PD-KR         
Rheumatology and Allergy Clinic Recruiting
Malang, Indonesia
Contact: Handono Kalim, Dr. Sp.PD-KR         
Rumah Sakit UD Dr. Saiful Anwar Recruiting
Malang, Indonesia
Contact: Cesarius Singgih Wahono, Dr. Sp.PD-KR         
Rumah Sakit TNI AU Soemitro Recruiting
Surabaya, Indonesia
Contact: Lita Diah Rahmawati, Dr. Sp.PD-KR         
Rumah Sakit UD Dr. Soetomo Recruiting
Surabaya, Indonesia
Contact: Yuliasih, Dr. Sp.PD-KR         
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Bambang Setyohadi, Dr. Sp.PD-KR Rumah Sakit Cipto Mangunkusumo
Principal Investigator: 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
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Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03434197    
Other Study ID Numbers: TPJ.01.2017
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taisho Pharmaceutical Co., Ltd.:
Osteoarthritis Knee Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action