NCT01539538

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Operative Pain

Interventions

Type	Name	Description
DRUG	Sufentanil NanoTab PCA System/15 mcg	15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
DRUG	morphine IV PCA	1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-02-27
• Last updated: 2015-10-01
• Results posted: 2014-03-27

Locations

16 sites across 1 country: United States