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


CONCLUSIONS
Nicoboxil/nonivamide ointment is an effective, well-tolerated medication for the treatment of acute non-specific low back pain.
Interdisciplinary Diagnostics and Therapy in the Academy for Manual Medicine, University Münster, Germany.
M
M
Gaubitz
Outpatient Clinic for Sports Traumatology and Public Health Consultation, German Sport University Cologne, Germany.
T
T
Schiffer
Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria.
C
C
Holm
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
E
E
Richter
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
W
W
Pisternick-Ruf
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
T
T
Weiser
D059787:Acute Pain / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D002211:Capsaicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009539:Nicotinic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D004338:Drug Combinations; D009539:Nicotinic Acids; C473307:nicoboxil; D002211:Capsaicin; C040937:nonivamide