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 |
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.
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
sites
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