Summary:
A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of investigational product compared to placebo in adult patients with active rotator cuff tendinopathy.
Qualified Participants Must:
Be willing and able to do MRI
Male and non-pregnant, non nursing females between 18-65 years old
Have rotator cuff tendinopathy for between 6 weeks and 6 months
Have nocturnal pain in shoulder on at least 3 out of 7 nights.
No previous surgery, or plans for surgery on the affected shoulder.
No injections of corticosteroids into shoulder in last 12 weeks
No injections of platelet rich plasmas into shoulder in last 12 months
Qualified Participants May Receive:
Compensation for time and travel.