NCT02143648

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: Trevi Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uremic Pruritus
• Pruritus

Interventions

Type	Name	Description
DRUG	nalbuphine HCl ER tablets 60 mg BID	nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
DRUG	nalbuphine HCl ER tablets 120mg BID	nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
DRUG	Placebo tablets BID	Placebo tablets BID administered for 8 weeks

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-05-21
• Last updated: 2025-05-21
• Results posted: 2020-09-07

Locations

47 sites across 3 countries: United States, Poland, Romania