NCT01539642

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Operative Pain

Interventions

Type	Name	Description
DRUG	Sufentanil NanoTab PCA System/15 mcg	15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
DRUG	Placebo Sufentanil NanoTab PCA System	Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2012-02-27
• Last updated: 2015-10-20
• Results posted: 2014-02-03

Locations

12 sites across 1 country: United States