NCT00449696

Gel-200 Versus Placebo in Osteoarthritis of the Knee

A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) in Osteoarthritis of the Knee.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 379 (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 intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Gel-200	Single intra-articular injection
DEVICE	Placebo	Single intra-articular injection

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-03-21
• Last updated: 2011-10-07
• Results posted: 2011-09-15

Locations

1 site across 1 country: United States