NCT02662764

Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg

Detailed description

320 adult postoperative in-patients, who met all study entry requirements, and were expected to require opioid analgesia for at least 24 hours, and up to 72 hours, after surgery were enrolled. Patients used the Zalviso™ (sufentanil sublingual tablet system) 15 mcg to self-administer a tablet of study drug as needed for pain. The System was evaluated for usability and functionality for up to 72 hours.

Conditions

• Moderate-to-severe Acute Pain

Interventions

Type	Name	Description
DRUG	Zalviso™ 15 mcg	Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours

Timeline

• Start date: 2016-09-28
• Primary completion: 2017-04-14
• Completion: 2017-05-05
• First posted: 2016-01-26
• Last updated: 2018-08-08
• Results posted: 2018-08-08

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study