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Osteoarthritis Knee PainPhase 3NCT03434197

Safety and Efficacy of SFPP in Knee Osteoarthritis

A Phase 3 study testing Esflurbiprofen and Diclofenac diethylamine in people with Osteoarthritis Knee Pain, run by Taisho Pharmaceutical Co., Ltd. at 11 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis Knee Pain
What is being tested?
Esflurbiprofen and Diclofenac diethylamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
11 sitesIndonesia
Study dates
5 Feb 2018to 11 Jan 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Indonesia11 sites

  • Klinik Perisai Husada

    Bandung

  • Rumah Sakit Hasan Sadikin

    Bandung

  • Rumah Sakit Umum Daerah Al Ihsan Bale Endah

    Bandung

  • Rumah Sakit Anna Medika Bekasi

    Jakarta

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta

  • Rumah Sakit Islam Pd. Kopi

    Jakarta

  • Rumah Sakit Siloam Karawaci

    Jakarta

  • Rheumatology and Allergy Clinic

    Malang

  • Rumah Sakit UD Dr. Saiful Anwar

    Malang

  • Rumah Sakit TNI AU Soemitro

    Surabaya

  • Rumah Sakit UD Dr. Soetomo

    Surabaya

Other trials in Indonesia

About this study

Official title: 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.

Being tested
Esflurbiprofen, Diclofenac diethylamine
Keywords
Osteoarthritis Knee Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsflurbiprofenDrug

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

  • Diclofenac diethylamineDrug

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

Study groups in NCT03434197
Study groupRoleWhat they receive
SFPP (Esflurbiprofen plaster)ExperimentalA plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
Receives: Drug: Esflurbiprofen
Diclofenac gelActive comparatorA gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)
Receives: Drug: Diclofenac diethylamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of Knee pain on rising from the chair

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

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

Secondary outcomes (6)

  1. Improvement of Changes in total clinical symptom

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

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

  2. Improvement of Investigator's global assessment

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

    Measured: Last visit

  3. Improvement of Patient's global assessment

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

    Measured: Last visit

  4. Improvement of Knee pain on walking

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

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

  5. Number of Rescue drug use during treatment period

    Report from investigator

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

  6. Number of Adverse events and adverse drug reactions

    Report from investigator

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2018
  2. Study start5 Feb 2018
  3. Primary completion11 Jan 2021
  4. Study completion11 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03434197
Sponsor's protocol ID
TPJ.01.2017
Status last verified
Aug 2021
First submitted
2 Feb 2018
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esflurbiprofen and Diclofenac diethylamine in people with Osteoarthritis Knee Pain, run by Taisho Pharmaceutical Co., Ltd. at 11 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03434197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.

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