A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control, Dose-Ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 [bupivacaine] for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy.
Phase of Trial: Phase II
Latest Information Update: 05 Aug 2013
At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 15 Dec 2010 According to a Pacira Pharmaceuticals Inc media release, the US FDA has accepted the NDA for Exparel [bupivacaine] for the treatment of postoperative pain.
- 22 Nov 2010 Primary endpoint 'Pain-intensity' has been met
- 19 Oct 2010 Results presented at the 2010 Annual Meeting of the American Society of Anesthesiologists.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History