Clinical Trial: Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

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

Official Title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Brief Summary: The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.

Detailed Summary:
Sponsor: Trevi Therapeutics

Current Primary Outcome: Overall incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Week 24 ]

Original Primary Outcome: A description of the overall incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Week 24 ]

Current Secondary Outcome: Incidence, frequency and nature of Treatment Emergent Adverse Events (TEAEs) during Treatment by achieved dose [ Time Frame: Week 3, Week 24 ]

Original Secondary Outcome: A description of the incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs) during Treatment by achieved dose [ Time Frame: Week 3, Week 24 ]

Information By: Trevi Therapeutics

Dates:
Date Received: May 19, 2014
Date Started: September 2014
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016