drugset / Trial / NCT03497975
PRISM Study-Pruritus Relief Through Itch Scratch Modulation
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-08-07
- Primary completion
- 2022-05-10
- Completion
- 2023-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalbuphine | Small molecule | 162 mg | Oral |