NCT00556608

Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis

Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Sinovial® (syringe containing sodium hyaluronate solution)	2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
DEVICE	Synvisc® ( syringe containing Hylan G-F 20 solution)	2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-07-01
• Completion: 2010-05-01
• First posted: 2007-11-12
• Last updated: 2012-12-04

Locations

20 sites across 6 countries: Czechia, France, Germany, Italy, Slovakia, Switzerland