A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL for Postsurgical Analgesia in Subjects Undergoing Total Shoulder Arthroplasty or Rotator Cuff Repair
Phase of Trial: Phase III
Latest Information Update: 02 Aug 2017
At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 02 Aug 2017 Status changed from recruiting to completed, according to a Pacira Pharmaceuticals media release.
- 02 Aug 2017 According to a Pacira Pharmaceuticals media release, the results of this and another phase III trial (see CT 269388) safety and pharmacokinetic data through 120 days, and data from other peripheral nerve block comparator studies will serve as the basis of an sNDA submission to the US FDA later this year, seeking expansion of the EXPAREL label to include administration via nerve block.
- 28 Apr 2017 Planned End Date changed from 1 Mar 2017 to 1 Jul 2017.