Tennis Elbow Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to Provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow)
A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Sodium Hyaluronate to provide Symptomatic Relief of Lateral Epicondylosis (Tennis Elbow).
The objective of this study is to assess the safety and effectiveness of two weekly peri-osteotendinous injections of OVT for relief of pain in patients with lateral epicondylosis in a multi-center, randomized, double-blind, placebo controlled superiority study. A total of 186 subjects will be enrolled at up to 20 centers in the US and Europe. The randomization ratio will be 2:1 (2 OVT subjects: 1 placebo subject). The entire study duration from first subject in to last subject out is approximately one year. The enrollment phase is approximately 6 months with a follow-up phase of 6 months. Visits are scheduled at baseline, 1 week, 4 weeks, 12 weeks, 18 weeks, and 26 weeks. Study injections will be given at the baseline and 1 week visits. ;
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