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Completed

NCT Number: NCT03434197

Safety and Efficacy of SFPP in Knee Osteoarthritis

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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Key information

Conditions

Osteoarthritis Knee Pain

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinik Perisai Husada, Bandung, Indonesia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esflurbiprofen

Drug

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

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2018
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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