Randomized controlled trial of the combined monoaminergic and opioid investigational compound GRT9906 in painful polyneuropathy

European Journal of Pain : EJP
S H SindrupT S Jensen

Abstract

GRT9906 is an investigational novel compound with μ-opioid receptor agonism and inhibition of noradrenalin/serotonin re-uptake. In this randomized, double-blind, placebo-controlled, three-way cross-over trial in painful polyneuropathy, the efficacy and safety of GRT9906 was assessed and compared with tramadol. During 4-week treatment periods, daily oral doses of either GRT9906 120-240 mg, or placebo, or tramadol 200-400 mg were given. These were separated by 1-week washout periods. The primary endpoint was the average pain intensity (average of daily current pain intensity over the last 3 days of each treatment period rated on a 0 to 10-point numeric rating scale). One hundred seventeen patients were enrolled and 64 were randomized to one of six treatment sequences. Forty-seven patients qualified for the per protocol analysis. GRT9906 reduced average pain intensity by 2.1 points compared with a reduction of 0.6 points on placebo (p < 0.0001) and 2.4 points on tramadol. GRT9906 also improved scores on the sleep problem scale and the neuropathic pain symptom inventory and scored better than placebo on the patient global impression of change. Numbers needed to treat to obtain one patient with more than 50% pain relief was 3.9 (95%...Continue Reading

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Citations

Aug 21, 2014·Postgraduate Medicine·Howard S SmithRonald J Tallarida
May 27, 2015·Journal of Clinical Epidemiology·Sebastian StraubeTim Friede
Dec 8, 2014·The Journal of Pain : Official Journal of the American Pain Society·Andrew McKeownShannon M Smith
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Oct 16, 2018·European Journal of Pain : EJP·Miriam Martínez-NavarroJosep-E Baños
Jun 21, 2017·The Cochrane Database of Systematic Reviews·Janna WarendorfNicolette C Notermans
Mar 1, 2016·Expert Review of Endocrinology & Metabolism·Dustin Anderson, Douglas W Zochodne
Jun 16, 2017·The Cochrane Database of Systematic Reviews·Rudolf Martin DuehmkeR Andrew Moore
Aug 1, 2020·Current Drug Safety·Johan RøikjerNiels Ejskjaer

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