Conditions: Uremic Pruritus Pruritus
Keywords: uremic pruritus itch chronic itch nalbuphine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 373
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: nalbuphine HCl ER tablets 60 mg BID arm 2: nalbuphine HCl ER tablets 120 mg BID arm 3: Placebo tablets BID

Interventions: intervention 1: nalbuphine HCl ER tablets 60 mg BID intervention 2: nalbuphine HCl ER tablets 120mg BID intervention 3: Placebo tablets BID
Intervention descriptions: intervention 1: nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks intervention 2: nalbuphine HCl ER tablets 120mg BID administered for 6 weeks intervention 3: Placebo tablets BID administered for 8 weeks

Protocol document: