Status:
COMPLETED
Gel-200 Versus Placebo in Osteoarthritis of the Knee
Lead Sponsor:
Seikagaku Corporation
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 osteoarthri...
Eligibility Criteria
Inclusion
- Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT00449696
Start Date
September 1 2006
End Date
December 1 2007
Last Update
October 7 2011
Active Locations (1)
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1
SKK
Plantation, Florida, United States, 33324