Approval Probability
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Adjusted LOA
ML Risk
hylan G-F 20, Buffered Saline · 1 trial · 2 indications
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
| Arm | Type | Description |
|---|---|---|
| Synvisc | EXPERIMENTAL | Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc). |
| Saline Control | PLACEBO_COMPARATOR | Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline. |
| Name | Type | Description |
|---|---|---|
| hylan G-F 20 | DEVICE | Single injection of 6 mL of hylan G-F 20 (Synvisc). |
| Phosphate Buffered Saline | OTHER | Single injection of 6 mL phosphate buffered saline. |
Inclusion Criteria: * Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 3 months prior to Screening, * Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee with at least 1 definite osteophyte and a measureable joint spa...
Hylan G-F 20 is used for symptomatic osteoarthritis of the knee. It is a buffered saline formulation being studied as a treatment for this condition. The drug is intended to address pain and functional limitations associated with knee osteoarthritis.
Hylan G-F 20 is developed by Sanofi, a global biopharmaceutical company. Sanofi is conducting clinical research on this product for knee osteoarthritis. The company's ticker symbol is SNY.
Hylan G-F 20 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development decisions.
Hylan G-F 20 has one completed Phase 3 trial, NCT00131352, which studied its safety and efficacy in patients with symptomatic osteoarthritis of the knee. The trial enrolled 253 participants across Belgium, Czechia, France, Germany, Netherlands, and the United Kingdom.
Yes, hylan G-F 20 is also known as Synvisc. The Phase 3 trial NCT00131352 specifically evaluated hylan G-F 20 (Synvisc) in patients with knee osteoarthritis. This alternative name is used in clinical research and medical literature.