NCT00379236

A Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Painful Osteoarthritis of the Knee

A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Painful Osteoarthritis of the Knee, With an Open-Label Safety Extension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 588 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This multicenter, randomized, double-blind study will be performed in approximately 600 subjects with chronic idiopathic osteoarthritis (OA) of the knee. An open-label safety extension will follow.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	EUFLEXXA™	EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate (molecular weight 2.4-3.6 MD); sodium chloride, 17 mg; disodium hydrogen phosphate dodecahydrate, 1.12 mg; sodium dihydrogen phosphate dihydrate, 0.1 mg; enough water for injection to make 2.0 ml. EUFLEXXA™ is supplied in 2.25 ml nominal volume, disposable prefilled glass syringes containing 2 mL of EUFLEXXA™. Only the contents of the syringe are sterile. EUFLEXXA™ is nonpyrogenic. See package insert for further details.
DEVICE	placebo	Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Only the contents of the syringe are sterile.

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-12-01
• Completion: 2008-05-01
• First posted: 2006-09-21
• Last updated: 2011-12-28
• Results posted: 2009-12-10

Locations

1 site across 1 country: United States