Gel-One Treatment in Knee Osteoarthritis



Status:Completed
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 80
Updated:4/21/2016
Start Date:August 2013
End Date:March 2016

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A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension

The purpose of this study is to determine whether Gel-One demonstrates a superior
effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS)
injections.


Inclusion Criteria:

- Have a knee pain

- Grade 1 to 3 on the Kellgren-Lawrence grading scale

Exclusion Criteria:

- BMI greater than 35 kg/m2

- Received an intra-articular hyaluronic acid injection for the treatment of OA of the
knee within 6 months prior to screening

- Had a joint replacement of the target knee
We found this trial at
41
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