Randomized, Multiple-Center, Double-Blind, Placebo-Controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-Operative Pain Following Orthopedic Trauma, Injury, or Surgery.
Phase of Trial: Phase III
Latest Information Update: 06 Apr 2017
At a glance
- Drugs Ketamine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Hospira; Javelin Pharmaceuticals
- 10 Jan 2012 Actual end date changed from Feb 2009 to Aug 2011 as reported by ClinicalTrials.gov.
- 12 Feb 2010 Primary endpoint 'Sum of pain intensity difference' has been met, after reexamination of topline data by third party.
- 12 Aug 2009 Primary endpoint 'Sum of pain intensity difference' has not been met.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History