Trying to relate these WOMAC results to the primary end point of 003 and it's not clear to me what a succesful result looks like.
The clinicaltrials.gov info lists the primary endpoint as:
Change from baseline at Day 56 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index. [ Time Frame: Baseline, Day 56 ]WOMAC: The WOMAC® NRS 3.1 Index is a validated, self-administered, health status questionnaire that assesses pain, stiffness, and function in patients with hip or knee OA . The WOMAC pain sub-scale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee) during the past 48 hours. It is calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain sub-scale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Seems like the endpoint is a bit subjective and we just need to see a change of satistical significance?
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