Randomized, double-blind, placebo-controlled trial of intra-articular CNTX-4975 (trans-capsaicin) for pain associated with osteoarthritis of the knee
Arthritis & Rheumatology Mar 26, 2019
Stevens RM, et al. - In this double-blind, multicenter, phase 2 study, authors studied 172 subjects to quantify the effectiveness and tolerability of high-purity synthetic trans-capsaicin (CNTX-4975) in individuals with chronic osteoarthritis-associated moderate to sharp knee pain. Subjects were randomized in a 2:1:2 ratio to receive a single, intra-articular injection of placebo, CNTX-4975 0.5 mg, or CNTX-4975 1.0 mg. They reported a remarkable decline in greater decreases in area under the curve (AUC) pain with CNTX-4975 vs placebo for the 0.5- and 1.0-mg groups (0.5 mg: LSMD, −0.79; 1.0 mg: LSMD, −1.6) at week 12. They noted comparable treatment-emergent adverse events in the placebo and 1.0-mg groups. They overall concluded dose-dependent improvement in knee OA-associated pain with CNTX-4975.
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