Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back - A randomized, controlled trial

BackgroundUntil now, nonivamide/nicoboxil ointment has not been tested in a randomized trial for the treatment of acute non-specific low back pain. MethodsThis phase III randomized, double-blind, active- and placebo-controlled, multi-centre trial investigated efficacy, safety and tolerability of topical nicoboxil 2.5%/nonivamide 0.4% for treatment of acute non-specific low back pain [primary endpoint: pain intensity (PI) difference between pre-dose baseline and 8h after the first application]. ResultsPatients (n=805), 18-74years of age were treated for up to 4days with nicoboxil 2.5%/nonivamide 0.4%, nicoboxil 2.5%, nonivamide 0.4% or placebo ointment. Pre-dose baseline pain intensity (6.6 on a 0- to 10-point numerical rating scale) was reduced by 1.049 points with placebo, by 1.428 points with nicoboxil, by 2.252 points with nonivamide and by 2.410 points with nicoboxil/nonivamide after 8h (p<0.0001 for nicoboxil/nonivamide vs. placebo, nicoboxil; p=0.4171 for nicoboxil/nonivamide vs. nonivamide). At the end of treatment, the combination provided more pronounced PI reduction (3.540 points) compared with nicoboxil (2.371, p<0.0001), nonivamide (3.074, p=0.0259) and placebo (1.884, p<0.0001). Low back mobility scores on Day 1 were better for the combination compared with all other treatments (p<0.044); on Day 2-4, scores were better than for placebo and nicoboxil (p<0.003). Patients assessed efficacy of the combination as greater than of the comparators (p0.0129). All treatments were tolerated well. No treatment-related serious adverse events were reported. ConclusionNicoboxil/nonivamide ointment is an effective, well-tolerated medication for the treatment of acute non-specific low back pain.