TY - JOUR
T1 - Civamide cream 0.075% in patients with osteoarthritis of the knee
T2 - A 12-week randomized controlled clinical trial with a longterm extension
AU - Schnitzer, Thomas J.
AU - Pelletier, Jean Pierre
AU - Haselwood, Doug M.
AU - Ellison, William T.
AU - Ervin, John E.
AU - Gordon, Richard D.
AU - Lisse, Jeffrey R.
AU - Archambault, W. Tad
AU - Sampson, Allan R.
AU - Fezatte, Heidi B.
AU - Phillips, Scott B.
AU - Bernstein, Joel E.
PY - 2012/3
Y1 - 2012/3
N2 - Objective. To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. Methods. We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. Results. A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline- by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. Conclusion. These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments. The Journal of Rheumatology
AB - Objective. To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. Methods. We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. Results. A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline- by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. Conclusion. These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments. The Journal of Rheumatology
KW - Double-blind study
KW - Osteoarthritis
KW - Phase 3
KW - TRPV-1 receptor
KW - Topical administration
KW - Zucapsaicin
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UR - http://www.scopus.com/inward/citedby.url?scp=84857879305&partnerID=8YFLogxK
U2 - 10.3899/jrheum.110192
DO - 10.3899/jrheum.110192
M3 - Article
C2 - 22089461
AN - SCOPUS:84857879305
SN - 0315-162X
VL - 39
SP - 610
EP - 620
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 3
ER -