Safety and Efficacy of SFPP in Knee Osteoarthritis

August 18, 2021 updated by: Taisho Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
313

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Bandung, Indonesia
        • Klinik Perisai Husada
      • Bandung, Indonesia
        • Rumah Sakit Hasan Sadikin
      • Bandung, Indonesia
        • Rumah Sakit Umum Daerah Al Ihsan Bale Endah
      • Jakarta, 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
      • Malang, Indonesia
        • Rheumatology and Allergy Clinic
      • Malang, Indonesia
        • Rumah Sakit UD Dr. Saiful Anwar
      • Surabaya, Indonesia
        • Rumah Sakit TNI AU Soemitro
      • Surabaya, Indonesia
        • Rumah Sakit UD Dr. Soetomo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 )
5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
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)
Last visit
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 )
Last visit
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 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
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
3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period)
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
5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taisho Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TPJ.01.2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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