Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain - a randomized, placebo-controlled trial

Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream...

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Bibliographic Details
Published in:Journal of pain research 2016-01, Vol.9, p.1221-1230
Main Authors: Blahova, Zuzana, Holm, Janina Claudia, Weiser, Thomas, Richter, Erika, Trampisch, Matthias, Akarachkova, Elena
Format: Article
Language:English
Subjects:
acute low back pain
Analgesics
Back pain
Backache
Care and treatment
Clinical trials
Drug dosages
mobility score
Narcotics
nicoboxil
nonivamide
Nonsteroidal anti-inflammatory drugs
Original Research
Pain
pain intensity reduction
Patients
Systematic review
topical cream
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Summary:Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain. This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score. Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points;
ISSN:1178-7090
1178-7090
DOI:10.2147/JPR.S118329