CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
nalbuphine HCl ER tablets 90 mg BID +2 moredrug
Likely dose
nalbuphine HCl ER tablets 90 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/NCT02174419
NCT02174419Phase 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 Prurigo Nodularis Patients

Trevi Therapeutics·interventional·Posted Jun 25, 2014·Updated May 21, 2025

In Brief

A Phase 3 clinical trial evaluating nalbuphine HCl ER tablets 90 mg BID, nalbuphine HCl ER tablets 180 mg BID, and 1 other intervention for Prurigo Nodularis and 3 related conditions. Completed, enrolled 62 participants across 4 sites in 3 countries.

Detailed Summary

The primary objectives of the study are 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 patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrurigo Nodularis, Nodularis Prurigo, Prurigo, Pruritus
CountriesGermany, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 25, 2014
Enrollment StartMar 1, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.0 years ago

Interventions

nalbuphine HCl ER tablets 90 mg BIDdrug

nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks

nalbuphine HCl ER tablets 180 mg BIDdrug

nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks

Placebo tablets BIDdrug

Placebo tablets BID administered for 10 weeks