Clinical Trial: Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

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 Hemodialysis Patients With Uremic P

Brief Summary: The primary objectives of the study 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 hemodialysis patients with moderate to severe uremic pruritus 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 Period (weeks 7 and 8) in itch on the 0-10 Itch Numerical Rating Scale [ Time Frame: Baseline, Week 7, Week 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from Baseline scores to the Evaluation Period (weeks 7 and 8) in the total Skindex-10 score [ Time Frame: Baseline, Week 7, Week 8 ]

Original Secondary Outcome: Same as current

Information By: Trevi Therapeutics

Dates:
Date Received: May 17, 2014
Date Started: June 2014
Date Completion:
Last Updated: October 20, 2016
Last Verified: October 2016