Primary Outcome Measures:
- Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days) [ Time Frame: 14 days ± 2 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- WOMAC: Change from the baseline of the pain subscale score at Visit 5 (Day 7 ±1 day), Visit 7 (Day 21 ±3 days) and Visit 8 (Day 28 ±3 days) [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
- WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
- WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
- Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Subject's Global Assessment at Visit 6 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
- Investigator's Global Assessment at Visit 6 and Visit 8 [ Time Frame: 28 days (±3 days) ] [ Designated as safety issue: No ]
The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.