CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 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/NCT02540265
NCT02540265Phase 2Completed

A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy

Baudax Bio·interventional·Posted Sep 3, 2015·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating N1539 and Intravenous Placebo for Pain, Post-operative. Completed, enrolled 59 participants across 1 site.

Detailed Summary

The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 3, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.8 years ago

Interventions

N1539drug

Intravenous Placebodrug