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

Seikagaku

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Device: Gel-200

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450112

Gel/1132

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous participation in study SI-6606/01.

Exclusion criteria

• Female subjects who are pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)