Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment

The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.

Time frame: baseline and 12 months

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year

The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)

Time frame: baseline and 12 months