drugset / Trial / NCT02174419
Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2015-03
- Primary completion
- 2016-08
- Completion
- 2016-08
Publications
- Eudy-Byrne R, Riggs M, Hawi A, Sciascia T, Rohatagi S. A population pharmacokinetic-pharmacodynamic model evaluating efficacy of nalbuphine extended-release in patients with prurigo nodularis. Br J Clin Pharmacol. 2023 Jul;89(7):2088-2101. doi: 10.1111/bcp.15663. Epub 2023 Feb 9.
- Stander S, Zeidler C, Pereira M, Szepietowski JC, McLeod L, Qin S, Williams N, Sciascia T, Augustin M. Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. J Eur Acad Dermatol Venereol. 2022 Apr;36(4):573-581. doi: 10.1111/jdv.17870. Epub 2022 Feb 14.
- Weisshaar E, Szepietowski JC, Bernhard JD, Hait H, Legat FJ, Nattkemper L, Reich A, Sadoghi B, Sciascia TR, Zeidler C, Yosipovitch G, Stander S. Efficacy and safety of oral nalbuphine extended release in prurigo nodularis: results of a phase 2 randomized controlled trial with an open-label extension phase. J Eur Acad Dermatol Venereol. 2022 Mar;36(3):453-461. doi: 10.1111/jdv.17816. Epub 2021 Dec 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalbuphine | Small molecule | 90 mg | Oral |
| Subject | Nalbuphine | Small molecule | 180 mg | Oral |