Clinical Trial: Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Trevi Therapeutics

Current Primary Outcome: Change from Baseline to the Evaluation Visit (Week 10) in itch on the 0-10 Numerical Rating Scale [ Time Frame: Baseline, Week 10 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from Baseline to the Evaluation Visit (Week 10) in the mean itch on the 0-10 Numerical Rating Scale [ Time Frame: Baseline, Week 10 ]

Original Secondary Outcome: Same as current

Information By: Trevi Therapeutics

Dates:
Date Received: June 24, 2014
Date Started: March 2015
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016