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

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

Outcome

Met primary endpoint

registry analysis (superiority or other test); Sufentanil NanoTab PCA System/15 mcg vs Morphine IV PCA; p = 0.007; Difference in proportion 12.90; t-test, 2 sided NCT01539538 ↗

release “the open-label Phase 3 study of its investigational sublingual (under the tongue) Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint” talphera.com ↗

release “Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p<0.001) to IV PCA morphine” talphera.com ↗

release “The third Phase 3 study, an open-label, active-comparator trial comparing Zalviso to IV PCA with morphine demonstrated that: Zalviso was non-inferior (p<0.001)” talphera.com ↗

release “In IAP309, a Phase 3 active-controlled study, Zalviso was statistically significantly superior (p=0.007) in patient global assessment ( PGA ) of method of pain control” talphera.com ↗

release “Each of the three Phase 3 trials achieved its primary endpoint.” talphera.com ↗

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.