Synopsis
A phase 2 study of XT-150 in patients with knee osteoarthritis (OA) required a pain score ≥ 8 (on a scale of 0-20) at the Screening visit for inclusion.  The Baseline visit occurred up to 30 days after screening and at that time, 50 patients out of 286 (17%) had pain scores <8.  Inclusion of patients based only on the screening score, without reconfirmation at baseline, allowed inclusion of patients with an overall lower pain score and could impact the eventual assessment of efficacy based on change in pain from the baseline visit.

 

Category
Clinical Trials, Methods and Evidence Synthesis
Musculoskeletal Pain