At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 219 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, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Abdominoplasty Surgery
In Brief
A Phase 3 clinical trial evaluating N1539 and Intravenous Placebo for Pain, Post-operative. Completed, enrolled 219 participants across 4 sites.
Detailed Summary
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following abdominoplasty surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Post-operative
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedFeb 2016
Primary CompletionOct 2016
Study CompletionNov 2016
TodayJul 2026
First PostedFeb 9, 2016
Enrollment StartJan 1, 2016
Primary CompletionOct 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago
Interventions
N1539drug
Intravenous Placebodrug