NCT02174419

Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Trevi Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prurigo Nodularis
• Nodularis Prurigo
• Prurigo
• Pruritus

Interventions

Type	Name	Description
DRUG	nalbuphine HCl ER tablets 90 mg BID	nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
DRUG	nalbuphine HCl ER tablets 180 mg BID	nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
DRUG	Placebo tablets BID	Placebo tablets BID administered for 10 weeks

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-06-25
• Last updated: 2025-05-21
• Results posted: 2020-08-21

Locations

4 sites across 3 countries: United States, Germany, Poland