CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 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.

Search/NCT02675907
NCT02675907Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Bunionectomy

Baudax Bio·interventional·Posted Feb 5, 2016·Updated Nov 17, 2017

In Brief

A Phase 3 clinical trial evaluating N1539 and Intravenous Placebo for Pain, Post-operative. Completed, enrolled 201 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 unilateral bunionectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Post-operative
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 5, 2016
Enrollment StartJan 1, 2016
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.4 years ago

Interventions

N1539drug

Intravenous Placebodrug