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NCT07096050: PMCF
Post Marketing Clinical Follow up Study of HyaleXo
NA trial testing HyaleXo in Knee Osteoarthritis in 101 participants. Completed in 25 April 2025.
14 February 2025
Quick facts
| Lead sponsor | Yooyoung Pharmaceutical Co., Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 2 August 2024 |
| Primary completion | 14 February 2025 |
| Estimated completion | 25 April 2025 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- HyaleXo
Conditions studied
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
Sponsor
Yooyoung Pharmaceutical Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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?
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07096050
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07507175 — Gastrocnemius Myofascial Release in Females With Knee Osteoarthritis · NA · recruiting
- NCT07386600 — Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA · NA · recruiting
Other Yooyoung Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT05362851 — Clinical Trial of YYC301 P3 for Treatment of Osteoarthritis of the Knee · Phase 3 · unknown
- NCT05226897 — Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients · Phase 3 · unknown
- NCT04858308 — Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506. · Phase 3 · unknown
- NCT04874129 — Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506 · Phase 1 · unknown
- NCT04874142 — Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07096050 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yooyoung Pharmaceutical Co., Ltd.
- Last refreshed: 31 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07096050.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing