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Effect of nalfurafine in severe itch in hemodialysis patients: A phase III, randomized, double-blind, placebo-controlled study

A 14-day, randomized, double-blind, placebo-controlled study investigated the effects of nalfurafine 2.5 ug or 5 ug orally in 337 hemodialysis patients with itch refractory to previous treatments. The primary endpoint was the mean decrease in a visual analogue scale (VAS) from baseline. This was decreased by both doses, but a significantly larger decrease was seen with the 5 ug dose versus placebo (P = 0.0002). Adverse events were seen in 35.1, 25.0 and 16.2% of patients in the 5 ug, 2.5 ug and placebo groups, respectively. The most common adverse event was sleep disturbance, seen in 24/226 nalfurafine patients. Nalfurafine was a useful drug in treating pruritus in patients refractory to ...