At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 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 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery
In Brief
A Phase 3 clinical trial evaluating N1539 and Placebo for Pain, Postoperative. Completed, enrolled 57 participants across 10 sites.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of Adverse Events (AEs) and Serious AEs (SAEs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedOct 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedOct 27, 2017
Enrollment StartOct 24, 2017
Primary CompletionSep 26, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.7 years ago
Interventions
N1539drug
Once Daily
Placebodrug
Once Daily