Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Summary

The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.

Timeline

Start

2014-06

Primary completion

2015-07

Completion

2015-07

Outcome

Met primary endpoint

release “and demonstrated statistically significant results on the primary, protocol-specified endpoint: reduction in worst itch severity as recorded by NRS score.” trevitherapeutics.com ↗

Publications

• Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Drugs

Indications