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Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back – A randomized, controlled trial
Author(s) -
Gaubitz M.,
Schiffer T.,
Holm C.,
Richter E.,
PisternickRuf W.,
Weiser T.
Publication year - 2016
Publication title -
european journal of pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.305
H-Index - 109
eISSN - 1532-2149
pISSN - 1090-3801
DOI - 10.1002/ejp.719
Subject(s) - placebo , tolerability , medicine , anesthesia , clinical endpoint , randomized controlled trial , adverse effect , alternative medicine , pathology
Background Until now, nonivamide/nicoboxil ointment has not been tested in a randomized trial for the treatment of acute non‐specific low back pain. Methods This 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 8 h after the first application]. Results Patients ( n = 805), 18–74 years of age were treated for up to 4 days 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 8 h ( 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 ( p ≤ 0.0129). All treatments were tolerated well. No treatment‐related serious adverse events were reported. Conclusion Nicoboxil/nonivamide ointment is an effective, well‐tolerated medication for the treatment of acute non‐specific low back pain.