Clinical Trial: Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
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 50 weeks.
Detailed Summary:
Sponsor: Trevi Therapeutics
Current Primary Outcome: Overall incidence frequency and nature of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Week 50 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence, frequency and nature of Treatment Emergent Adverse Events (TEAEs) during Treatment by achieved dose [ Time Frame: Week 4, Week 50 ]
Original Secondary Outcome: Same as current
Information By: Trevi Therapeutics
Dates:
Date Received: June 24, 2014
Date Started: August 2015
Date Completion: July 2017
Last Updated: September 13, 2016
Last Verified: September 2016