At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 167 enrolled
Drug / intervention
nalbuphine HCl ERdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
In Brief
A Phase 3 clinical trial evaluating nalbuphine HCl ER for Uremic Pruritus and Pruritus. Completed, enrolled 167 participants across 35 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUremic Pruritus, Pruritus
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartSep 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedMay 21, 2014
Enrollment StartSep 1, 2014
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.1 years ago
Interventions
nalbuphine HCl ERdrug
nalbuphine HCl ER