CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 373 enrolled
Drug / intervention
nalbuphine HCl ER tablets 60 mg BID +2 moredrug
Likely dose
nalbuphine HCl ER tablets 60 mg BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02143648
NCT02143648Phase 3Completed
CompareCT.gov

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

Trevi Therapeutics·interventional·Posted May 21, 2014·Updated May 21, 2025

In Brief

A Phase 3 clinical trial evaluating nalbuphine HCl ER tablets 60 mg BID, nalbuphine HCl ER tablets 120mg BID, and 1 other intervention for Uremic Pruritus and Pruritus. Completed, enrolled 373 participants across 47 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUremic Pruritus, Pruritus
CountriesPoland, Romania, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 21, 2014
Enrollment StartJun 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.1 years ago

Interventions

nalbuphine HCl ER tablets 60 mg BIDdrug

nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks

nalbuphine HCl ER tablets 120mg BIDdrug

nalbuphine HCl ER tablets 120mg BID administered for 6 weeks

Placebo tablets BIDdrug

Placebo tablets BID administered for 8 weeks