Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery

Phase 2 Completed 59 enrolled Baudax Bio

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-08
Primary completion: 2015-11
Completion: 2015-11

Publications

Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Meloxicam	Small molecule	30 mg	Intravenous
Subject	Meloxicam	Small molecule	60 mg	Intravenous

Indications

No indication recorded.