At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 353 enrolled
Drug / intervention
Nalbuphine ER Tablets +1 moredrug
Likely dose
Not stated in 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.
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)
In Brief
A Phase 3 clinical trial evaluating Nalbuphine ER Tablets and Placebo Tablets for Prurigo Nodularis. Completed, enrolled 353 participants across 70 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrurigo Nodularis
CountriesAustria, France, Germany, Poland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartAug 2018
Primary CompletionMay 2022
Study CompletionFeb 2023
TodayJul 2026
First PostedApr 13, 2018
Enrollment StartAug 7, 2018
Primary CompletionMay 10, 2022
Study CompletionFeb 24, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.2 years ago
Interventions
Nalbuphine ER Tabletsdrug
Active Nalbuphine ER Tablets
Placebo Tabletsdrug
Placebo matching NAL ER with no active substance