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Safety and Efficacy of SFPP in Knee Osteoarthritis

NCT ID: NCT03434197

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2021-01-11

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SFPP (Esflurbiprofen plaster)

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

Group Type EXPERIMENTAL

Esflurbiprofen

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

Diclofenac diethylamine

Intervention Type 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)

Interventions

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Esflurbiprofen

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

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bambang Setyohadi, Dr. Sp.PD-KR

Role: STUDY_CHAIR

Rumah Sakit Cipto Mangunkusumo

Sumariyono, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Cipto Mangunkusumo

Tanggo Meriza, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Islam Pd. Kopi

Sandra Sinthya Langow, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Siloam Karawaci

Ika Wulan Yuliani, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Anna Medika Bekasi

Sumartini Dewi, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Hasan Sadikin

Andri Reza, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit Umum Daerah Al Ihsan Bale Endah

Laniyati Hamijoyo, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Klinik Perisai Husada

Yuliasih, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit UD Dr. Soetomo

Lita Diah Rahmawati, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit TNI AU Soemitro

Cesarius Singgih Wahono, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rumah Sakit UD Dr. Saiful Anwar

Handono Kalim, Dr. Sp.PD-KR

Role: PRINCIPAL_INVESTIGATOR

Rheumatology and Allergy Clinic

Locations

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Klinik Perisai Husada

Bandung, , Indonesia

Site Status

Rumah Sakit Hasan Sadikin

Bandung, , Indonesia

Site Status

Rumah Sakit Umum Daerah Al Ihsan Bale Endah

Bandung, , Indonesia

Site Status

Rumah Sakit Anna Medika Bekasi

Jakarta, , Indonesia

Site Status

Rumah Sakit Cipto Mangunkusumo

Jakarta, , Indonesia

Site Status

Rumah Sakit Islam Pd. Kopi

Jakarta, , Indonesia

Site Status

Rumah Sakit Siloam Karawaci

Jakarta, , Indonesia

Site Status

Rheumatology and Allergy Clinic

Malang, , Indonesia

Site Status

Rumah Sakit UD Dr. Saiful Anwar

Malang, , Indonesia

Site Status

Rumah Sakit TNI AU Soemitro

Surabaya, , Indonesia

Site Status

Rumah Sakit UD Dr. Soetomo

Surabaya, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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TPJ.01.2017

Identifier Type: -

Identifier Source: org_study_id

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