Osteoarthritis, KneeNCT05829798
An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
A study testing SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in people with Osteoarthritis, Knee, run by Aptissen SA at 3 sites in Poland.
Trial summary
Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- SYNOLIS VA 80/160 and SYNOLIS VA 40/80
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesPoland
- Study dates
- 14 Jan 2021to 1 Oct 2021
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 35 and 75 years old
- Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:
- Knee pain
- Positive radiography (presence of osteophytes)
- Morning stiffness < 30 min and/or crepitus while walking
- Symptoms related to knee osteoarthritis for at least 6 months
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- Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
- Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
- WOMAC pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
- Contralateral knee pain < 10 mm (VAS) compared to treated knee
- Patient signed inform consent form-
Who cannot join
- Inability to understand the study or language used to be informed/sign the consent
- Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
- Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
- Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
- Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
- Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
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- Rheumatoid arthritis, joint condition or any other inflammation and arthritis
- Lupus
- Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
- Visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
- Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
- Osteonecrosis (1 or both knees)
- Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study
- Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
- Fibromyalgia
- Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
- Excessive and repeated consumption of alcohol or illicit substances
- Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
SPORTO Spółka z o.o.
Lodz, 09-038
Klinika Chirurgii Kolana Dr Słynarskiego
Warsaw, 02-672
NZOZ Carolina Medical Center - Sport Medica S.A
Warsaw, 02-757
About this study
Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks
- Conditions
- Osteoarthritis, Knee
- Being tested
- SYNOLIS VA 80/160, SYNOLIS VA 40/80
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNOLIS VA 80/160Device
Single 4mL intra-articular injection of SYNOLIS VA 80/160
SYNOLIS VA 40/80Device
Single 2mL intra-articular injection of SYNOLIS VA 40/80
| Study group | Role | What they receive |
|---|---|---|
| SYNOLIS VA 80/160 | Experimental | SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) Intra-articular injection Receives: Device: SYNOLIS VA 80/160 |
| SYNOLIS VA 40/80 | Experimental | SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg) Intra-articular injection Receives: Device: SYNOLIS VA 40/80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Measured: 168 days
Secondary outcomes (6)
Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Measured: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Measured: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Measured: up to 168 days
Percentage of subjects using analgesics
New NSAID / analgesics drugs usage
Measured: up to 168 days
Measurement of relief satisfaction by the patient
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Measured: 168 days
Measurement of therapeutic efficacy by the investigator (assessor)
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start14 Jan 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptissen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Noblewell
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829798
- Sponsor's protocol ID
- PMCF2-4ML single injection
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05829798
- Acronym / sponsor ID
- PMCF2-4ML single injection
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee Osteoarthritis, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aptissen SAIndustry (pharma, biotech, devices)
- Collaborators
- Noblewell
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 26 Apr 2023 (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.
Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNOLIS VA 80/160 | Experimental | Device: SYNOLIS VA 80/160SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) Intra-articular injection |
| SYNOLIS VA 40/80 | Experimental | Device: SYNOLIS VA 40/80SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg) Intra-articular injection |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient between 35 and 75 years old
- Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:
- Symptoms related to knee osteoarthritis for at least 6 months
- Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
- Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
Key exclusion criteria (18 listed)
- Inability to understand the study or language used to be informed/sign the consent
- Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
- Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
- Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
- Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
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 |
|---|---|---|
| SYNOLIS VA 80/160Single 4mL intra-articular injection of SYNOLIS VA 80/160 | Device | SYNOLIS VA 80/160 |
| SYNOLIS VA 40/80Single 2mL intra-articular injection of SYNOLIS VA 40/80 | Device | SYNOLIS VA 40/80 |
Primary outcome
Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
Time frame: 168 days
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
6 secondary outcomes
Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0
Time frame: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0
Time frame: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0
Time frame: up to 168 days
Percentage of subjects using analgesics
Time frame: up to 168 days
Measurement of relief satisfaction by the patient
Time frame: 168 days
Measurement of therapeutic efficacy by the investigator (assessor)
Time frame: 168 days
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 26 Apr 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in people with Osteoarthritis, Knee, run by Aptissen SA at 3 sites in Poland.
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 11 inclusion and 18 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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.
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?
Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit (time frame: 168 days). 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 26 Apr 2023.