clinical trial · NCT03497975
PRISM Study-Pruritus Relief Through Itch Scratch Modulation
Prurigo NodularisNalbuphine ER TabletsPlacebo Tablets
brief summary
To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets in Prurigo Nodularis. Participants were randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, participants who received NAL ER were continued on NAL ER and participants who received placebo would then shift to NALER.
started
Aug 7, 2018
primary completion
May 10, 2022
completion
Feb 24, 2023
last updated
Jun 24, 2025
official title
A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol