A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy
Phase of Trial: Phase II
Latest Information Update: 31 Jul 2017
At a glance
- Drugs Meloxicam (Primary)
- Indications Postoperative pain
- Focus Adverse reactions
- Sponsors Recro Pharma
- 31 Jul 2017 According to a company media release, lRecro Pharma has submitted an NDA to the US FDA for intravenous (IV) meloxicam 30mg for the treatment of moderate to severe, acute postoperative pain. The NDA is supported by positive results from two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, a large double-blind Phase III safety trial and four Phase II clinical trials for the management of moderate to severe postoperative pain.
- 07 Sep 2016 Data from this trial will be presented at PAINWeek, the National Conference on Pain for Frontline Practitioners, according to a Recro Pharma media release.
- 15 Jan 2016 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History