At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 722 enrolled
Drug / intervention
N1539 +1 moredrug
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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
In Brief
A Phase 3 clinical trial evaluating N1539 and Intravenous Placebo for Pain, Post-operative. Completed, enrolled 722 participants across 32 sites in 4 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of N1539 in a variety of post-surgical conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Post-operative
CountriesAustralia, Canada, New Zealand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMar 2016
Primary CompletionMar 2017
Study CompletionMay 2017
TodayJul 2026
First PostedMar 28, 2016
Enrollment StartMar 1, 2016
Primary CompletionMar 1, 2017
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.3 years ago
Interventions
N1539drug
Intravenous Placebodrug