drugset / Trial / NCT02143648

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

NCT02143648

Phase 2/3 Completed 373 enrolled Trevi Therapeutics
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalbuphine Small molecule 60 mg
Subject Nalbuphine Small molecule 120 mg

Indications