NCT02662556

A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Detailed description

This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.

Conditions

• Acute Moderate-to-severe Pain

Interventions

Type	Name	Description
DRUG	sufentanil sublingual tablet 30 mcg	sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2016-01-25
• Last updated: 2017-03-15
• Results posted: 2017-03-15

Locations

2 sites across 1 country: United States