Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00131352 | A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee | PHASE3 | COMPLETED | 253 | — | — | May 1, 2005 | Sep 1, 2006 | Apr 3, 2015 | 21 | Belgium, Czechia +4 |
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...