Trial Profile
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 14 Dec 2020
Price :
$35
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At a glance
- Drugs Bupivacaine (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Pacira Pharmaceuticals
- 02 Mar 2015 Pacira Pharmaceuticals has received a Complete Response Letter from the U.S. FDA following a review of its sNDA for the use of EXPAREL in nerve block to provide postsurgical analgesia, according to a media release.
- 18 Apr 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
- 27 Feb 2014 Top-line phase III results reported in a Pacira Pharmaceuticals media release.