NCT02356588

A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (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 sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.

Conditions

• Post-Operative Pain

Interventions

Type	Name	Description
DRUG	Sufentanil Tablet 30 mcg
DRUG	Placebo Tablet

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-06-01
• Completion: 2015-08-01
• First posted: 2015-02-05
• Last updated: 2017-02-13
• Results posted: 2017-02-13

Locations

4 sites across 1 country: United States