New study on Diethylamine

Diethylamine is a secondary amine with the molecular structure CH3CH2NHCH2CH3 (also written as C4H11N). It is a flammable, strongly alkaline liquid. It is miscible with water and ethanol. It is a colorless liquid which often appears brown due to impurities. It is volatile and has a strong unpleasant odor, the Molecular Weight is 73.14, and CAS Registry Number is 109-89-7.

Topical diclofenac Diethylamine 1.16% gel is an NSAID that is clinically proven to be effective and well tolerated in acute and chronic musculoskeletal conditions. Applied topically, diclofenac penetrates the skin barrier to reach joints, muscles and synovial fluid. It preferentially distributes and persists in the target inflamed tissues, achieving a sufficiently high concentration to exert local therapeutic activity. 

Therefore, this randomized, double-blind, placebo-controlled study aimed to assess its efficacy and safety in the treatment of acute NP. The primary objective of the study was to assess the efficacy of Diethylamine(CAS NO:109-89-7) 1.16% gel compared with placebo gel in the treatment of acute NP in terms of pain-on-movement at 48 h (Day 3) from baseline. Secondary objectives included the effect of Diethylamine 1.16% gel on pain-at-rest (PAR), functional impairment (using the neck disability index, NDI), patients’ global assessment of treatment efficacy and safety following application for 5 days.

The clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization Harmonized Tripartite Guidelines for Good Clinical Practice and with the ethical principles laid down in the Declaration of Helsinki. The study protocol, protocol amendment and associated documents were reviewed by an Independent Ethics Committee in Germany. Informed consent was obtained from each subject in writing before randomization and the rights of subjects were protected.

The primary efficacy variable was POM after 48 h. Secondary efficacy variables included POM at all other visits, PAR and NDI score at Days 2, 3 and 5, response to treatment, early response to treatment, global assessment of treatment efficacy at Days 3 and 5 and use of rescue medication.

In total, 72 subjects were randomized to treatment between April 2011 and July 2011; 36 to Diethylamine 1.16% gel and 36 to placebo gel. All 72 patients completed the study and were included in the ITT population. The mean age was 33.8 years, with an almost equal number of males and females, and all subjects were Caucasian. 

Overall, subjects had neck pain at baseline for about 10 days, an NDI score (24.5) midway the best and worst outcomes (0, 50), mild-to-moderate PAR (40.6 mm) and severe POM (75.5 mm). The treatment groups did not differ appreciably on any demographic or baseline neck pain characteristics. In particular, POM in the Diethylamine 1.16% gel and placebo groups were comparable at baseline (77.2 mm vs. 73.8 mm, respectively).

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