Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
NCT00450112 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202
Last updated 2011-08-22
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
- DEVICE
-
Gel-200
Single Intra-articular Injection
Sponsors & Collaborators
-
Seikagaku Corporation
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2009-06-30
- Completion
- 2009-06-30
Countries
- United States
Study Locations
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