Knee OsteoarthritisPMCFNCT07096050
Post Marketing Clinical Follow up Study of HyaleXo
A study testing HyaleXo in people with Knee Osteoarthritis, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in Romania.
Trial summary
Hyaluronic acid is a polysaccharide naturally present in several human tissues such as cartilage. It is the major constituent of synovial fluid and provides its viscosity and elasticity. In traumatic and degenerative joint diseases, the amount of hyaluronic acid is reduced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- HyaleXo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteRomania
- Study dates
- 2 Aug 2024to 25 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old (inclusive ≥ 18 years).
- Men or women.
- Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases (clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with OA at both knees, only the most painful one will be included in the study.
- VAS knee pain ≥ 40 mm at screening and 30 days before.
- Patients willing and able to comply with study terms.
- Patients willing to discontinue all other OA treatments
Who cannot join
- Patients that are unable or unwilling to provide informed consent, and/or patients participating in a concurrent clinical trial and/or patients who have participated in a similar clinical trial within the last days.
- Patients with known hypersensitivity to any components of investigational product.
- Patients who are pregnant or breastfeeding. Patients with infected or severely inflamed joints.
- Patients with skin diseases or infections in the area of the injection site.
- Patients with hepatic failure or history thereof.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HyaleXo for Pain Relief in Patients Suffering From Osteoarthritis or Degenerative Joint Diseases
Hyaluronic acid is a polysaccharide naturally present in several human tissues such as cartilage. It is the major constituent of synovial fluid and provides its viscosity and elasticity. In traumatic and degenerative joint diseases, the amount of hyaluronic acid is reduced. The consequent loss of viscosity by the synovial fluid may be the cause of painful symptoms. HyaleXo action, according to its composition (sodium hyaluronate of very high molecular weight), may restore the viscoelastic properties of synovial fluid, attenuate pain and improve the mobility of the joint. These characteristics allow HyaleXo to be used for the symptomatic relief of pain in patients suffering from osteoarthritis (OA) or degenerative joint diseases causing an alteration of the functionality of the synovial fluid.
The patient will be treated with HyaleXo as reported in the Instruction for use (IFU) of the device: via injection once a week for 3 weeks using standard technique. The patient pain management strategy should be according to the standard clinical practices and remains at the discretion of the investigator.
The Research Question of the present study is the following: in a population of men and women suffering from painful knee osteoarthritis or degenerative joint disease will very high molecular weight fraction of sodium Hyaluronate (HyaleXo) significantly decrease and / or relieve the pain after 1,6,12 weeks and 6 months of the third injection?
- Conditions
- Knee Osteoarthritis
- Being tested
- HyaleXo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaleXoOther
Treatment of HyaleXo 3 times
| Study group | Role | What they receive |
|---|---|---|
| Patients that meet inclusion/exclusion criteria. | Other | Patients that meet inclusion/exclusion criteria. Receives: Other: HyaleXo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional assessment of HyaleXo by KOOS
Functional assessment of HyaleXo by KOOS (Knee Injury and Osteoarthritis Outcome score) for Pain subscale at 12 weeks after the last administration of the investigational product, compared to the baseline.
Measured: 12 weeks
Secondary outcomes (6)
Functional assessment of HyaleXo by KOOS
Functional Assessment of HyaleXo by KOOS for other Symptoms, Activity of Daily Living (ADL), Sport and Recreation (Sport/Rec) function and knee related Quality of life (QoL) at 1, 6, 12 weeks and 6 months after the last administration of the investigational product, compared to baseline
Measured: 1,6,12 weeks and 6 months
Functional assessment of HyaleXo by KOOS
Functional Assessment of HyaleXo by KOOS for Pain subscale at 1, 6 weeks and 6 months after the last administration of the investigational product, compared to baseline
Measured: 1,6 weeks and 6 months
Visual Analgoue Sclae
- Changes in the weight-bearing pain using a Visual Analogue Scale (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.
Measured: 1,6,12 weeks and 6 months
Visual Analgoue Sclae
- Changes in the rest pain (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.
Measured: 1,6,12 weeks and 6 months
Visual Analgoue Sclae
- Changes in the motion pain (pain after 15 m walk) (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.
Measured: 1,6,12 weeks and 6 months
Patient Global Pain Assessment
- Patient Global Pain Assessment (100 mm - VAS) at 1, 6, 12 weeks and 6 months after the last administration, compared to the baseline.
Measured: 1,6,12 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start2 Aug 2024
- Primary completion14 Feb 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096050
- Sponsor's protocol ID
- YYDATP-PMCF-RO
- Acronym
- PMCF
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- 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 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HyaleXo for Pain Relief in Patients Suffering From Osteoarthritis or Degenerative Joint Diseases
- ClinicalTrials.gov ID
- NCT07096050
- Acronym / sponsor ID
- PMCF / YYDATP-PMCF-RO
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- TigerMed
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 31 Jul 2025 (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.
Hyaluronic acid is a polysaccharide naturally present in several human tissues such as cartilage. It is the major constituent of synovial fluid and provides its viscosity and elasticity. In traumatic and degenerative joint diseases, the amount of hyaluronic acid is reduced. The consequent loss of viscosity by the synovial fluid may be the cause of painful symptoms. HyaleXo action, according to its composition (sodium hyaluronate of very high molecular weight), may restore the viscoelastic properties of synovial fluid, attenuate pain and improve the mobility of the joint. These characteristics allow HyaleXo to be used for the symptomatic relief of pain in patients suffering from osteoarthritis (OA) or degenerative joint diseases causing an alteration of the functionality of the synovial fluid.
The patient will be treated with HyaleXo as reported in the Instruction for use (IFU) of the device: via injection once a week for 3 weeks using standard technique. The patient pain management strategy should be according to the standard clinical practices and remains at the discretion of the investigator.
The Research Question of the present study is the following: in a population of men and women suffering from painful knee osteoarthritis or degenerative joint disease will very high molecular weight fraction of sodium Hyaluronate (HyaleXo) significantly decrease and / or relieve the pain after 1,6,12 weeks and 6 months of the third injection?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients that meet inclusion/exclusion criteria. | Other | Other: HyaleXoPatients that meet inclusion/exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 18 years old (inclusive ≥ 18 years).
- Men or women.
- Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases (clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with OA at both knees, only the most painful one will be included in the study.
- VAS knee pain ≥ 40 mm at screening and 30 days before.
- Patients willing and able to comply with study terms.
Key exclusion criteria (5 listed)
- Patients that are unable or unwilling to provide informed consent, and/or patients participating in a concurrent clinical trial and/or patients who have participated in a similar clinical trial within the last days.
- Patients with known hypersensitivity to any components of investigational product.
- Patients who are pregnant or breastfeeding. Patients with infected or severely inflamed joints.
- Patients with skin diseases or infections in the area of the injection site.
- Patients with hepatic failure or history thereof.
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 |
|---|---|---|
| HyaleXoTreatment of HyaleXo 3 times | Other | Patients that meet inclusion/exclusion criteria. |
Primary outcome
Functional assessment of HyaleXo by KOOS
Time frame: 12 weeks
Functional assessment of HyaleXo by KOOS (Knee Injury and Osteoarthritis Outcome score) for Pain subscale at 12 weeks after the last administration of the investigational product, compared to the baseline.
6 secondary outcomes
Functional assessment of HyaleXo by KOOS
Time frame: 1,6,12 weeks and 6 months
Functional assessment of HyaleXo by KOOS
Time frame: 1,6 weeks and 6 months
Visual Analgoue Sclae
Time frame: 1,6,12 weeks and 6 months
Visual Analgoue Sclae
Time frame: 1,6,12 weeks and 6 months
Visual Analgoue Sclae
Time frame: 1,6,12 weeks and 6 months
Patient Global Pain Assessment
Time frame: 1,6,12 weeks and 6 months
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 31 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyaleXo in people with Knee Osteoarthritis, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in Romania.
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 6 inclusion and 5 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 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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?
Functional assessment of HyaleXo by KOOS (time frame: 12 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 31 Jul 2025.