A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Phase 3 Completed 357 enrolled Talphera, Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

Timeline

Start: 2012-04
Primary completion: 2012-12
Completion: 2012-12

Publications

Background Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 2014 Nov;14(8):679-88. doi: 10.1111/papr.12238. Epub 2014 Aug 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Morphine	Other / unclassified	1 mg	Intravenous
Subject	Sufentanil	Other / unclassified	15 ug	Other

Indications

No indication recorded.