NCT00131352

A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee

A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.

Detailed description

The trial included an initial 26 week treatment with 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control) followed by a 4 week repeat treatment of Synvisc.

Conditions

• Osteoarthritis, Knee
• Musculoskeletal Diseases

Interventions

Type	Name	Description
DEVICE	hylan G-F 20	Single injection of 6 mL of hylan G-F 20 (Synvisc).
OTHER	Phosphate Buffered Saline	Single injection of 6 mL phosphate buffered saline.

Timeline

• Start date: 2005-05-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-08-18
• Last updated: 2015-04-03
• Results posted: 2012-01-19

Locations

21 sites across 6 countries: Belgium, Czechia, France, Germany, Netherlands, United Kingdom