NCT00988091

Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee

A 26 Week, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Single Intra-Articular Injection 1.2% Sodium Hyaluronate for Treatment of Painful Osteoarthritis of the Knee, With Optional 26-Week Open-Label Safety Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	1.2% Sodium Hyaluronate	IA-BioHA is supplied in a disposable 7 ml nominal volume glass syringe containing 60 mg/5 ml of 1.2% sodium hyaluronate. Participants are given a single injection in the target knee on Day 1 of the double-blind period and optionally on the first day of the open-label period (approximately week 27).
DEVICE	Buffered Saline	IA-SA is supplied in a disposable 7 ml nominal volume glass syringe containing 5 ml of phosphate buffered saline. Participants are given a single injection in the target knee on Day 1 of the double-blind period.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-10-01
• Completion: 2011-04-01
• First posted: 2009-10-01
• Last updated: 2012-06-15
• Results posted: 2012-06-04

Locations

34 sites across 1 country: United States