Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

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 total unilateral knee or total unilateral hip replacement surgery.

Timeline

Start

2012-08

Primary completion

2013-04

Completion

2013-05

Outcome

Met primary endpoint

registry Sufentanil NanoTab PCA System/15 mcg vs Placebo Sufentanil NanoTab PCA System; p <0.001; Mean Difference (Final Values) 87.59 (95% CI 66.20 to 108.98); ANCOVA NCT01660763 ↗

release “Following major orthopedic surgery, Sufentanil NanoTab-treated patients experienced significantly greater reduction in pain as measured by SPID-48 vs. placebo (p<0.001)” talphera.com ↗

Publications

• Background Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746.

Drugs

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

Indications

No indication recorded.