Gel-200 Versus Placebo in Osteoarthritis of the Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT00449696

Run by

Seikagaku Corporation

People needed

379

Starts

2006-09-01

Expected to finish

2007-12-01

Last updated by the study team

2011-10-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

You may not qualify if…

• Subjects with Grade 4 on K-L score
• Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
• Serious systemic diseases
• Female subjects who are pregnant or lactating

Where it is running

• SKK — Plantation, Florida, United States

Full record on ClinicalTrials.gov

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