OsteoarthritisPhase 3NCT04421911
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac
A Phase 3 study testing Ketoprofen topical and Diclofenac Topical in people with Osteoarthritis, run by Handok Inc. at 9 sites in Russia.
Trial summary
Primary objective: To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score Secondary objectives: To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ketoprofen topical and Diclofenac Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 9 sitesRussia
- Study dates
- 20 Mar 2020to 1 Sep 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-75 years
- Compliance to ACR diagnostic criteria of OA of the knee
- Patients with Kellgren-Lawrence grade 1-3
- Index knee pain should be ≥40 mm on VAS (100mm) scale
Who cannot join
- Intolerance or allergic reactions to the study therapy
- Usage of NSAIDs within 3 days
- Open skin lesions or dermatological conditions at the site of plaster application
- Surgery or major trauma of the index knee within the previous 12 months
- Pregnant or breast-feeding women
- Alcohol addiction, drug addiction or drug abuse in the past
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
Maksimum Zdorovya
Kemerovo
City Clinical Hospital #1 n.a. Pirogova
Moscow
Rostov State Medical University
Rostov-on-Don
Ryazan State Medical University n.a. I.P.Pavlov
Ryazan
Saratov State Medical University n.a. V.I.Razumovsky
Saratov
Private Healthcare Institution Smolensk Russian Railway Clinical Hospital
Smolensk
Ulyanovsk Regional Clinical Hospital
Ulyanovsk
Regional Clinical Hospital
Vladimir
Clinical Emergency Hospital n.a. N.V.Soloviev
Yaroslavl
About this study
Official title: A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis
Primary objective:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score
Secondary objectives:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints.
- To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups
Read the detailed description
This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis
- Conditions
- Osteoarthritis
- Being tested
- Ketoprofen topical, Diclofenac Topical
- Keywords
- ketoprofen, diclofenac, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen topicalDrug
Ketoprofen topical for 21days
Diclofenac TopicalDrug
Diclofenac topical for 21days
| Study group | Role | What they receive |
|---|---|---|
| ketoprofen | Experimental | Not described Receives: Drug: Ketoprofen topical |
| Diclofenac | Active comparator | Not described Receives: Drug: Diclofenac Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in walking arthritis pain intensity score
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
Measured: 3 weeks
Secondary outcomes (4)
Mean change in spontaneous arthritis pain intensity score
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
Measured: 3 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale)
Measured: 3 weeks
Global Impression of Improvement (PGI-I)
Patient Global Impression of Improvement (PGI-I) assessment
Measured: 3 weeks
Adverse events
frequency, severity, relationship with the study drug
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 Mar 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421911
- Sponsor's protocol ID
- KETO-2019
- Status last verified
- Jan 2021
- First submitted
- 2 Jun 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT04421911
- Acronym / sponsor ID
- KETO-2019
- Conditions
- Osteoarthritis
- Keywords
- ketoprofen, diclofenac, osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score
Secondary objectives:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints.
- To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups
Detailed description
This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketoprofen | Experimental | Drug: Ketoprofen topical |
| Diclofenac | Active comparator | Drug: Diclofenac Topical |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 40-75 years
- Compliance to ACR diagnostic criteria of OA of the knee
- Patients with Kellgren-Lawrence grade 1-3
- Index knee pain should be ≥40 mm on VAS (100mm) scale
Key exclusion criteria (6 listed)
- Intolerance or allergic reactions to the study therapy
- Usage of NSAIDs within 3 days
- Open skin lesions or dermatological conditions at the site of plaster application
- Surgery or major trauma of the index knee within the previous 12 months
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketoprofen topicalKetoprofen topical for 21days | Drug | ketoprofen |
| Diclofenac TopicalDiclofenac topical for 21days | Drug | Diclofenac |
Primary outcome
Mean change in walking arthritis pain intensity score
Time frame: 3 weeks
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
4 secondary outcomes
Mean change in spontaneous arthritis pain intensity score
Time frame: 3 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3 weeks
Global Impression of Improvement (PGI-I)
Time frame: 3 weeks
Adverse events
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketoprofen topical and Diclofenac Topical in people with Osteoarthritis, run by Handok Inc. at 9 sites in Russia.
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 4 inclusion and 6 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. 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?
Mean change in walking arthritis pain intensity score (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2021.