Gel-200 Versus Placebo in Osteoarthritis of the Knee

Seikagaku

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Device: Placebo; Device: Gel-200

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449696

SI-6606/01

Details and patient eligibility

About

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.

Enrollment: 379 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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379 participants in 2 patient groups, including a placebo group

Gel-200

Experimental group

Treatment:

Device: Gel-200

PBS

Placebo Comparator group

Treatment:

Device: Placebo