Osteoarthritis Knee Pain Relief Study of 0.25% 920-CGS-200
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
This is a study of an over-the-counter, capsaicin-based (0.25%) topical analgesic for
management of osteoarthritis knee pain meeting the US Food and Drug Administration's (FDAs)
Tentative Final Monograph (TFM) guidance for "External Analgesic Drug Products For
Over-the-Counter Human Use," published in the Federal Register on February 8, 1983 (final
proposed 21 CFR 348). Subjects meeting the inclusion criteria and not meeting the exclusion
criteria were randomized into one of four groups: once daily treatment with active product,
once daily treatment with product vehicle (no capsaicin), twice daily treatment with active
product, and twice daily treatment with product vehicle (no capsaicin), all for 7 consecutive
days of treatment. The twice daily treatments were spaced approximately 12 hours apart.
Osteoarthritis knee pain was assessed by the 100 mm visual analog scale. Osteoarthritis knee
pain assessments were done each day for 28 days. Tolerability data were also collected.