At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 194 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 3b, Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Open Unilateral Total Knee Arthroplasty
In Brief
A Phase 3 clinical trial evaluating N1539 and Placebo for Pain, Postoperative. Completed, enrolled 194 participants across 6 sites.
Detailed Summary
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartFeb 2018
Primary CompletionMay 2019
TodayJul 2026
First PostedFeb 15, 2018
Enrollment StartFeb 19, 2018
Primary CompletionMay 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.4 years ago
Interventions
N1539drug
Once Daily
Placebodrug
Once Daily