NCT06528600

Comparative Study of Two Hyaluronic Acid Formulation in the Management of Knee Osteoarthritis

A Randomized, Double-Blind, Active Controlled, Multi-Center, Non- Inferiority Study of One-injection of Hymovis ONE (32 mg/4ml) Against Currently Approved 1-injection Regimen of Monovisc in Symptomatic Relief of Osteoarthritis of the Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Fidia Farmaceutici s.p.a. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens. This study consists of a 2-week period for screening, one baseline treatment visit, and a 26- week evaluation phase. Subjects will be randomized to receive a single intra-articular (IA) injection of either Hymovis ONE® or Monovisc™ into the knee using an 18-20 gauge needle.

Detailed description

This is a multi-center, randomized, double-blind, active comparator-controlled, non-inferiority study to assess the efficacy and safety of a single injection of Hymovis ONE® for the relief of pain in subjects with OA of the knee by establishing its non-inferiority to Monovisc™. The entire study will last approximately 19 months. Patients will participate in the study for approximately 28 weeks (from screening to the last visit). The study is designed to compare the effectiveness and safety of a single injection of Hymovis ONE® to a single injection of Monovisc™. Both products are high molecular weight HA preparations, specifically sodium hyaluronate from bacterial fermentation, supplied sterile as a single dose of 4 ml in a 5 ml syringe. Subjects will undergo an evaluation consisting of a thorough discussion of medical history, demographics, followed by a physical examination and vital signs (blood pressure and heart rate) measurement. The evaluation of their activity level through the Tegner activity level scale, a graduated list of ADLs, recreation, and competitive sports will be performed. The patient is asked to select the level of participation that best describes their current level of activity through an Investigator's interview. The Tegner activity level scale is filled in by Investigator. In this study, one single IA injection of Hymovis ONE® or Monovisc™ will be performed at the investigational site, under the tight supervision of an experienced treating specialist. Therefore, there are no expected risks of misuse in the administration of the investigational products according to treatment schedule defined in the study protocol. Furthermore, the use of only one IA injection should further contribute to limit the risk of adverse effects. Therefore, it is expected that benefits from participation in this study will outweigh the potential risks.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Hymovis ONE	Single injection of Hymovis ONE®, a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens
DEVICE	Monovisc	Single injection of Monovisc™ a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens

Timeline

• Start date: 2020-09-16
• Primary completion: 2024-03-15
• Completion: 2024-06-15
• First posted: 2024-07-30
• Last updated: 2024-07-30

Locations

19 sites across 1 country: Italy