Summary:
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of four different concentrations of SM04690 injected into the target knee joint of moderately to severely symptomatic OA subjects.
This is a new type of drug that could potentionially enhance cartilage formation. In addition, general medical evaluations including physical examination, knee examination, and recording of vital signs will be performed at Screening Visit 1, Day 1, and Weeks 4, 12, and 24. Height will be measured at Screening Visit 1 and weight will be measured at Screening Visit 1 and Week 2. Clinical laboratory evaluations will be performed at Screening Visit 1 and Weeks 4, 12, and 2. Radiographic imaging of the knees will be performed at Screening Visit 1 and Week 24. You will be required to complete an electronic diary to monitor progress. This study is a 1 time injection into the OA knee.
Qualified Participants Must:
• Be between 40 and 80 years of age
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Be diagnosed with osteoarthritis of the knee by a physician
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Be ambulatory without the use of walking assistance
Qualified Participants May Receive:
$50.00 for Screening Visit and sign consent. $50.00 for Screening visit 2. $75.00 Day 1. $50.00 for week 4, 12, and 24. For total study completion. Patient will recieve a total of $325.00.