NCT00450112

Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Seikagaku Corporation · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Gel-200	Single Intra-articular Injection

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-03-21
• Last updated: 2011-08-22
• Results posted: 2011-08-22

Locations

1 site across 1 country: United States