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Safety and Efficacy of SFPP in Knee Osteoarthritis

Primary Purpose

Osteoarthritis Knee Pain

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Esflurbiprofen

Diclofenac diethylamine

About this trial

This is an interventional treatment trial for Osteoarthritis Knee Pain focused on measuring Osteoarthritis Knee Pain

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SFPP (Esflurbiprofen plaster)

Diclofenac gel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement of Knee pain on rising from the chair

0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

Secondary Outcome Measures

Improvement of Changes in total clinical symptom

Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 )

Improvement of Investigator's global assessment

Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)

Improvement of Patient's global assessment

Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )

Improvement of Knee pain on walking

0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

Number of Rescue drug use during treatment period

Report from investigator

Number of Adverse events and adverse drug reactions

Report from investigator

Full Information

NCT ID

NCT03434197

First Posted

February 2, 2018

Last Updated

August 18, 2021

Sponsor

Taisho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03434197

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

February 5, 2018 (Actual)

Primary Completion Date

January 11, 2021 (Actual)

Study Completion Date

January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taisho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis Knee Pain

Keywords

Osteoarthritis Knee Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

313 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SFPP (Esflurbiprofen plaster)

Arm Type

Experimental

Arm Description

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

Arm Title

Diclofenac gel

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Esflurbiprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Diclofenac diethylamine

Intervention Description

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 Measure Information:

Title

Improvement of Knee pain on rising from the chair

Description

0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

Time Frame

5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Secondary Outcome Measure Information:

Title

Improvement of Changes in total clinical symptom

Description

Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 )

Time Frame

5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Title

Improvement of Investigator's global assessment

Description

Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)

Time Frame

Last visit

Title

Improvement of Patient's global assessment

Description

Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )

Time Frame

Last visit

Title

Improvement of Knee pain on walking

Description

0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)

Time Frame

5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Title

Number of Rescue drug use during treatment period

Description

Report from investigator

Time Frame

3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period)

Title

Number of Adverse events and adverse drug reactions

Description

Report from investigator

Time Frame

5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials: