At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 36 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 Prurigo Nodularis Patients
In Brief
A Phase 3 clinical trial evaluating nalbuphine HCl ER for Prurigo Nodularis and 2 related conditions. Completed, enrolled 36 participants across 1 site.
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 50 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrurigo Nodularis, Nodularis Prurigo, Prurigo
CountriesGermany
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartAug 2015
Primary CompletionSep 2017
TodayJul 2026
First PostedJun 25, 2014
Enrollment StartAug 15, 2015
Primary CompletionSep 3, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago
Interventions
nalbuphine HCl ERdrug
nalbuphine HCl ER BID for up to 50 weeks