A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

Phase 3 Completed 172 enrolled Talphera, Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.

Timeline

Start: 2012-02
Primary completion: 2013-01
Completion: 2013-02

Publications

Background Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	15 ug	Subcutaneous

Indications

No indication recorded.